FDA Market Authorizations: AEMCOLO for travelers’ diarrhea, YULPERI for COPD, GAMIFANT for rare immune disease, DAURISMO for AML

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AEMCOLO (rifamycin) AEMCOLO (rifamycin) delayed-release tablets

Cosmo Technologies, Ltd

INDICATION: Treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli in adults

  • Limitations of Use: Not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.

ADDRESSING UNMET NEED: 

  • Travelers’ diarrhea affects 10–40 % travelers worldwide each year
  • Highest-risk destinations in most of Asia as well as the Middle East, Africa, Mexico, and Central and South America

MECHANISM OF ACTION: Antibacterial drug

EFFICACY:

  • Multi-center, randomized, double-blind, placebo (Guatemala, Mexico)  and active-controlled (India, Guatemala and Ecuador) trials
  • Primary endpoint: Time to last unformedstool (TLUS) before achieving clinical cure
  • AEMCOLO significantly reduced the TLUS compared to placebo (p=0.0008); supportive outcome ina ctive controlled trial.

SAFETY: 

  • Most common adverse reactions (incidence > 2%): Headache and constipation

REGULATORY PATHWAY: NDA

  • Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act
  • Priority Review
  • Deferred pediatrkc studies: Treatment of travelers’ diarrhea in children from 6 – 11 years of age and 12-17 years of age

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YUPELRI™ (revefenacin) inhalation solution

Theravance and Mylan

INDICATION: Mtreatment of patients with chronic obstructive pulmonary disease (COPD)

MECHANISM OF ACTION: Long-acting muscarinic antagonist, inhibition of M3 receptor at the smooth muscle leading to bronchodilation

EFFICACY:

  • Two dose-ranging trials, two replicate 12-week, Phase 3 confirmatory clinical trials, and a 52-week safety trial
  • Confirmatory Trials: n=1,229 subjects, YUPELRI vs. placebo once daily
  • Primary endpoint: Change from baseline in trough (predose) Forced Expiratory Volume in One Second or FEV1  at Day 85
  • Significant improvement in lung function vs placebo

SAFETY:

  • Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo):  Cough, nasopharyngitis, upper respiratory tract infection, headache, back pain
  • Worsening of narrow-angle glaucoma may occur

REGULATORY PATHWAY: NDA

  • Pediatric requirements waived

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Novimmune SA

INDICATION: Treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or
progressive disease or intolerance with conventional HLH therapy

ADDRESSING UNMET NEED:

  • Primary HLH is rare and life-threatening condition typically affecting children
  • Approval fills an unmet medical need for these patients

MECHANISM OF ACTION: Monoclonal antibody that binds to and neutralizes interferon gamma

EFFICACY:

  • Clinical trial of 27 pediatric patients,  with suspected or confirmed primary HLH,  intolerant of conventional HLH therapy
  • 63% experienced response and 70 % were able to proceed to stem cell transplant

SAFETY:

  • Common side effects: Infections, hypertension, infusion-related reactions, low potassium and fever
  •  Patients should not receive any live vaccines and should be tested for latent tuberculosis
  • Patients should be closely monitored and treated promptly for infections

REGULATORY PATHWAY: BLA

  • Orphan designation, Priority Review and Breakthrough Therapy designation

LABEL


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DAURISMO (glasdegib) tablets

Pfizer

INDICATION: In combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

  • Limitation of Use: Has not been studied in patients with the comorbidities of severe renal impairment or moderate-to-severe hepatic impairment

MECHANISM OF ACTION: Hedgehog pathway inhibitor, binds to and inhibits Smoothened, a transmembrane protein involved in hedgehog signal transduction

EFFICACY:

  • Multicenter, openlabel, randomized study, n=115 patients with newly-diagnosed AML, DAURISMO with low-dose Cytarabine va. low-dose Cytarabine
  • Primary Endpoint: Overall Survival; 8.3 mo. vs 4.3 mo, p=0.0002

SAFETY:

  • Boxed warning: Can cause embryo-fetal death or severe birth defects
  • Most common adverse reactions (incidence ≥20%): Anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, rash

REGULATORY PATHWAY: NDA

  • Orphan and Priority designations

LABEL


Image credits: Cosma, Theravance, Novimmune, Pfizer

FDA News and Views: Transforming 510(k) Program, Increased Medical Device Inspections, Social Media Trends for Drug Use, Drug Use Software, Addressing Drug Shortages, Waiver or Alteration of Informed Consent

CaptureTransformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

Changes to modernize  510(k) clearance pathway, which accounts for majority of FDA reviews

  • To keep pace with increasing complexity of rapidly evolving technology
  • To efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety

Reliance on more modern predicate devices or objective performance criteria

  • Predicates that are <10 years old
  • Public website on cleared devices with substantial equivalence to older predicates
  • Rename new approach the “Safety and Performance Based Pathway
    • Focus on advancing improved safety and performance of new products
    • Ensure novel device meets modern performance-based criteria that reflect current technological principles

Report on Strengthening the 510(k) program

  • Increased premarket expectations
  • Implemented a Refuse-To-Accept policy to improve the quality of submissions
  • Improved consistency and thoroughness of review
  • Eliminated use of 510(k) for Class III devices
  • Eliminated use of > 1000 510(k)s as legal predicates

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CaptureFDA’s increased inspections of medical device manufacturers and targeted risk-based approach leads to improved compliance

FDA has increased its oversight through additional device inspections since 2007

  • Increase in annual number of device inspections by 46%
  • Increased annual inspections of foreign firms by 243%
  • Established Medical Device Single Audit Program to allow for a single audit on behalf of multiple countriesf  urther increased the FDA’s oversight of foreign manufacturing facilities
  • Targeted risk-based approach to addressing concerns with specific devices e.g. infusion pumps, automated external defibrillators
  • Increased compliance actions and voluntary recalls leading to better compliance, improved device quality, reduction in reported injuries and deaths
  • Identifying reporting deficiencies during inspections leading to increase in voluntary recalls and adverse event reporting
  • Case for Quality initiative that includes a voluntary quality maturity appraisal pilot launched this year.

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 Monitoring Social Media to Better Understand Drug Use Trends

Proactive pharmacovigilance using nontraditional monitoring process is to identify and analyze content found in conversations occurring online and on social media sites

  • Inform prescription drug use or abuse – explore in greater depth through more detailed and rigorous primary data collection efforts
  • Use data gleaned from social media monitoring –  inform communications activities, identify potential new trends
  • Methods to monitor social media platforms – Twitter, Facebook, Instagram, also forums, blogs, discussion groups, news sites, and other nontraditional sites
  • Recognize benefits and limitations
  • EXAMPLE- Gabapentinoids use increase – focus on misuse and abuse based on online conversations

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Prescription Drug-Use-Related Software

“Prescription drug-use-related software” refers to:

  • Software (e.g. App) disseminated by or on behalf of a drug sponsor
  • Accompanies one or more of the sponsor’s prescription drugs, including biological drug products

Proposed framework takes risk-based approach to prescription drug use-related software

  • Anticipated that output of such software will not require FDA review prior to dissemination
  • Dependent on whether software is a ‘device’ per CDRH assessment

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New Efforts to Address Drug Shortages

Ensuring that necessary drug is available to patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution 

  • Immediate need: External factors (bioterror attacks, natural disasters)
  • Long-term need : Interagency Drug Shortages Task Force to investigate root causes  and take new approach to advance long-term solutions
  • Public engagement: Upcoming public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions

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Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Allow responsible IRB to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent or waives requirement to obtain informed consent 

  • Clinical investigation involves no more than minimal risk to subjects
  • Waiver or alteration of informed consent will not adversely affect rights and welfare of subjects
  • Clinical investigation could not practicably be carried out without waiver or alteration of informed consent
  • Whenever appropriate, subjects will be provided with additional pertinent information after participation

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Image credits: FDA

FDA Market Authorization: ADCETRIS for peripheral T-cell lymphoma, DPP Ebola Test, picoAMH Test for Menopause, INNOVO electrical stimulatory for incontinence

Capture.JPGAdcetris (brentuximab vedotin) injection

Seattle Genetics

EXPANDED INDICATION: Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), in combination with cyclophosphamide, doxorubicin, and prednisone

ADDRESSING UNMET NEED:

  • First approval for treatment of newly diagnosed PTCL
  • Use of new Real-Time Oncology Review (RTOR) program to complete approval more quickly; access key data prior to the official submission of application allowing review team to begin review prior to the application’s actual submission

EFFICACY: 

  • Trial, n=452 patients with certain PTCLs who received either Adcetris plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment
  • Progression-free survival:  Significantly longer (hazard ratio 0.71, P-value 0.01) in the Adcetris arm (median 48 months, compared to 21 months with CHOP)
  • Survival and overall response rates were also significantly better in the Adcetris arm

SAFETY:

  • Boxed Warning: JC virus infection resulting in PML
  • Most common side effects: Peripheral neuropathy, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever and anemia
  • Monitor for infusion reactions, life-threatening anaphylaxis, neuropathy, fever, gastrointestinal complications and infections, tumor lysis syndrome,  serious skin reactions, pulmonary toxicity and hepatotoxicity.

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Capture.JPGDPP Ebola Antigen System

ChemBio Diagnostic

INTENDED USE: The is a rapid, single-use immunochromatographic test intended for the qualitative detection of VP40 protein from Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in capillary “fingerstick” whole blood, EDTA venous whole blood, and EDTA plasma

ADDRESSING UNMET NEED:

  • Rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus)
  • Second Ebola rapid antigen fingerstick test available
  •  Collaboration with  Federal, international and industry partners to assist in global response to Ebola outbreak in Democratic Republic of Congo

DESCRIPTION: 

  • Single-use immuno-chromatographic, rapid test developed on Chembio’s patented DPP® technology
  • DPP® Micro Reader which is used to interpret test results

REGULATORY PATHWAY: Emergency Use Authorization

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CapturepicoAMH ELISA Menopause Test

Ansh Labs

INDICATION FOR USE: Enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative measurement of anti-Müllerian hormone (AMH), also known as Müllerian Inhibiting Substance (MIS), concentrations in human serum. It is intended to be used as an aid in the determination of menopausal status in women between 42 and 62 years of age. This assay should only be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. It is intended for in vitro diagnostic use and for prescription use only

ADDRESSING UNMET NEED: 

  • Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms
  • Can help inform discussions about preventative care e.g. prevent loss in bone mineral density or to address cardiovascular disease, both of which increase after menopause

GENERIC DEVICE TYPE: Menopause test system

  • In vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women

EFFECTIVENESS AND SAFETY:

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  • Data from multi-center, longitudinal Study of Women’s Health Across the Nation (SWAN), n= 690 women, aged 42 to 62
  • PicoAMH Elisa test performed reasonably well
    • determining AMH levels of AMH in blood
    • identifying women who had their last menstrual period
    • identifying women who were more > five years away from last menstrual period

RISKS & MITIGATIONS:

  • Incorrect test results: General controls and special controls
  • Incorrect interpretation of test results: General controls and special controls

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 862.1093
  • Regulation Name: Menopause test system
  • Regulatory Class: Class II
  • Product Code: QDH

CLASSIFICATION ORDER


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INNOVO 

Atlantic Therapeutics Group

INDICATION FOR USE: Transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. Indicated for prescription use only.

GENERIC DEVICE TYPE: Transcutaneous electrical continence device

  • Consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence

EFFECTIVENESS AND SAFETY:

  • Two randomized controlled trials in EU and US
  • US trial: 87.2% of patients were dry or mild of after a 12-week treatment period1, with 93% of patients experiencing improvement in 4 weeks

RISKS & MITIGATIONS

  • Pain or tissue damage due to overstimulation: Non-clinical performance testing
    Software verification, validation, and hazard analysis, Electrical safety testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • Electrical shock or burn: Electrical safety testing, Software verification, validation, and hazard analysis, Labeling
  • Device failure due to electromagnetic interference: Electromagnetic compatibility (EMC) testing, Software verification, validation, and hazard analysis, Labeling
  • Use error that may result in user discomfort, injury, or delay in treatment: Software verification, validation, and hazard analysis, Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 876.5330
  • Regulation Name: Transcutaneous electrical continence device
  • Regulatory Class: Class II
  • Product Code: QAJ

CLASSIFICATION ORDER


Image Credits: Seattle Genetics, ChemBio, Ansh Labs, Atlantic Therapeutics

FDA News & Views: MyStudies App, Asthma and OTC Treatment, Improving Expanded Access, Modernizing Sterile Drug Inspections

Capture.JPGFDA MyStudies app

MyStudies app will aid researchers and industry in collecting real world patient level data

  • When linked to existing electronic health data
  • Will promote efficiencies in drug development and drug safety monitoring processes
  • Patients can securely enroll and participate in large scale pragmatic clinical trials or registries
  • Comply with FDA guidance and regulations regarding data authenticity, integrity, and confidentiality (21 CFR Part 11 compliant clinical trials)

Two versions of the app

  • Apple ResearchKit (iOS) framework
  • Open source ResearchStack framework, which runs on Google’s Android

App (iOS and Android), web configuration portal (WCP), and storage environment posted on GitHub to allow customization and use 

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Asthma Management and OTC Treatment Option

About 8.3 percent of Americans — nearly 27 million people — have asthma

  • No cure for asthma and, in most cases, don’t know causes
  • Can reduce the number and severity of attacks
  • Develop an asthma action plan – with right medications

OTC Primatene Mist for temporary relief for symptoms of mild, intermittent asthma

  • Original OTC Primatene Mist taken off market in 2011- contained chlorofluorocarbon (CFC) propellants known to deplete the ozone layer
  • New version recently approved
  • Uses same active bronchodilator ingredient (epinephrine)
  • Redesigned device for use n people ages 12 years and older

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PRIMATENE MIST


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New efforts to strengthen FDA’s expanded access program

Expanded Access (EA) program provides pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials

Steps taken for improvement

  •  streamlining the required supporting documentation
  • simplified the process for Institutional Review Board (IRB) review
  • guidance on use of safety data

Additional improvements based on independent assessment

  • mproving FDA’s public website content and investing in resources to support patient/physician program navigation
  • formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program,
  • Implementing Right to Try legislation

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New Inspection Protocol Project (NIPP) to strengthen and modernize  inspections for sterile injectable drugs

New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight

  • Quickly assess state of quality in drug manufacturing facilities while maintaining flexibility to adapt inspections based on constraints e.g.  time or seriousness of violations
  • Easier to analyze data to find anomalies and inform decisions that can reduce risks to patients
  • Ensure more streamlined and consistent coverage and reporting of inspectional activities
  • Multiple pilots of NIPP protocols conducted
  • Integrate learnings into field activities – goal to have full implementation within two years

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Image credit: FDA

FDA Market Authorizations: VISUMAX Laser, BIOMIMICS 3D Stent, PERSONAL GENOME SERVICE Pharmacogenetic Reports, FLUOBEAM 800 Clinic Imaging Device, Biosimilars: UDENCYA, HYRIMOZ

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VisuMax Femtosecond Laser

 Carl Zeiss Meditec, Inc.

INDICATION FOR USE: In small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism:

  • For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters
  • For cylinder from -0.75 diopters through -3.00 diopters
  • When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude

DESCRIPTION

  • Precision ophthalmic surgical laser designed for creation of incisions in cornea
  • Mimics cutting action of mechanical or blade-based keratomes
  • Accomplishes this by scanning tightly focused patterns of femtosecond laser pulses in cornea at precise and predefined positions and depths
  • Each laser pulse produces micro-photodisruption in tissue of only a few microns in size
  • Patterns of contiguous, focused laser pulses results in the creation of continuous cut surfaces in cornea

EFFECTIVENESS & SAFETY:

  • 12-month, prospective, multi-center, open-label, non-randomized clinical trial, 360 eyes of 360 consecutive subjects for reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D
  • The key effectiveness variables : Predictability: the percentage of eyes achieving MRSE within ± 1.00 D of the intended outcome,  Improvement in UCVA following treatment: the percentage of eyes that achieve uncorrected visual acuity (UCVA) of 20/40 or better
  • Predictability of MRSE: 99.1%
  • Improvement in UCVA: 98.6%
  • Most serious types of adverse events : 3 cases of intraoperative cap tears, several of the cases of epithelium in the interface, all objective types of adverse events occurred at rates less than 1%, no objective findings resulted in long-term serious sequelae

REGULATORY PATHWAY: PMA

  • Device Procode: OTL

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BioMimics 3D Vascular Stent System

Veryan Medical Limited

INDICATION FOR USE: To improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery, with reference vessel diameters ranging from 4.0 – 6.0 mm and lesion lengths up to 140 mm

DESCRIPTION:

  • Comprised of two components; (i) a Nitinol stent with a 3D helical profile in a range of lengths and diameters and (ii) an over-the-wire stent delivery system
  • 3D stent is a peripheral self-expanding nickel-titanium alloy (Nitinol)stent with 3D helical centerline geometry
  • Stent is laser cut from a straight Nitinol tube and 3D helical geometry is stored in the Nitinol shape memory
  • Three tantalum radiopaque markers are located at both ends of the stent to increase visibility of the stent to aid in placemen
  • 3D stent is mounted on a 6F over-the-wire stent delivery system (SDS) for use with a 0.035” guidewire

EFFECTIVENESS & SAFETY:

  • Prospective, single-arm, multicenter clinical trial,  in patients with intermittent claudication due to atherosclerotic disease of the femoropopliteal artery
  • Primary effectiveness endpoint: Primary stent patency rate at 12 months: 73%
  • Freedom from Major Adverse Event (MAE) comprising death, any major amputation performed on the target limb through 30 days: 99.6%

REGULATORY PATHWAY: PMA

  • Device Procode: NIP
  • Device Generic Name: Stent, Superficial Femoral Artery

LABEL 


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 Personal Genome Service (PGS) Pharmacogenetic Reports

23andMe

INDICATION FOR USE: Qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare professional.

The 23andMe Personal Genome Service Pharmacogenetic Reports are indicated for reporting of the following variants:

Gene Variant(s)
CYP2C19 *2, *3, *17
CYP2C9 *2, *3, *5, *6, rs7089580
CYP3A5 *3
UGT1A1 *6, *28
DPYD *2A, rs67376798
TPMT *2, *3C
SLCO1B1 *5
CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41

ADDRESSING UNMET NEED: 

  • Making information about genetic variants available directly to consumers
  • Better inform their discussions with their health care providers

GENERIC DEVICE TYPE: Pharmacogenetic assessment system

Qualitative in vitro molecular diagnostic system intended to detect nucleic acid variants isolated from human specimens for the purpose of identifying pharmacogenetic associations for the detected variants. The intended use of the device must not include an indication for use in supporting or sustaining human life, being of substantial importance in preventing impairment of human health, or presenting a potential, unreasonable risk of illness or injury.

EFFECTIVENESS & SAFETY: 

  • Data to show that the test is accurate (i.e., can correctly identify the genetic variants in saliva samples)
  • Provide reproducible results
  • Data on user comprehension studies that demonstrated that the test instructions and reports were understood by consumers
  • Test report provides information describing what the results might mean, what the test does not do and how to interpret results.

RISKS & MITIGATIONS:

  • Incorrect test results (false positive or false negative results): Special controls
  • Incorrect interpretation of test results: Special controls
  • Incorrect action based on test results: Special controls

REGULATORY PATHWAY: De Novo classification request

  • Regulation Number: 21 CFR 862.3364
  • Regulation Name: Pharmacogenetic assessment system
  • Regulatory Class: Class II
  • Product Code: QDJ

CLASSIFICATION ORDER


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Fluobeam 800 Clinic Imaging Device

Fluoptics

INDICATION FOR USE:  To provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluoptics Fluobeam® Imaging system is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The Fluoptics Fluobeam® Imaging system can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.

Use of the Fluobeam® device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

ADDRESSING UNMET NEED:  Provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).

GENERIC TYPE OF DEVICE: Autofluorescence detection device for general surgery and dermatological use.

  • Adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.

EFFECTIVENESS & SAFETY:

  • Data from five peer-reviewed published studies, including one study that compared the rate of postoperative hypocalcemia (PH), or a temporary reduction in calcium in the blood, that occurs when healthy parathyroid tissue is inadvertently removed, n=93
  • 5 % experienced fluctuating PH following surgery (n=93) vs  21 % (n=153) patients who had surgery without the device

RISKS & MITIGATIONS:

  • Electrical, mechanical, or thermal hazards leading to user injury or discomfort:  Electromagnetic compatibility testing Electrical, mechanical and thermal safety testing, Software verification, validation, and hazard analysis, Labeling
  • Tissue, skin burn, or eye injury due to light and laser exposure: Light and laser exposure safety testing, Labeling
  • Infection and cross-contamination: Sterilization validation, Shelf life testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • False identification of target tissues or structures leading to errors in patient
    management (e.g., removal of healthy tissue or not removing diseased tissue): In vivo performance testing, Software verification, validation, hazard analysis, Labeling

REGULATORY PATHWAY: De Novo classification request

  • Previously cleared, via 510(k) pathway, as an imaging system used to capture and view fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion
  • De Novo pathway for new indication
  • Regulation Number: 21 CFR 878.4550
  • Regulation Name: Autofluorescence detection device for general surgery and dermatological use
  • Regulatory Class: Class II
  • Product Code: QDG

CLASSIFICATION ORDER


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Biosimilars: UDENCYA (pegfilgrastim-cbqv), HYRIMOZ (adalimumab-adaz)

Biosimilar product: Biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product.

UDENCYA (pegfilgrastim-cbqv) injection, biosimilar to NEULASTA (pegfilgrastim)

INDICATION: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

HYRIMOZ (adalimumab-adaz) injection, biosimilar to HUMIRA (adalimumab)

INDICATIONS: 
  • Rheumatoid Arthritis: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HYRIMOZ can be used alone or in combination with methotrexate or other non- biologic disease-modifying anti-rheumatic drugs (DMARDs).
  • Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate.
  • Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs.
  • Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Adult Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HYRIMOZ is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
  • Ulcerative Colitis: Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).
  • Plaque Psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

LABEL


Image credits: Carl Zeiss Meditec, Veryan Medical Limited, 23andMe, Fluoptics, FDA

FDA News and Views: Cybersecurity, Digital Health Advisor, Stakeholder update, Dsuvia Opioid Approval, E-cigarette cessation drugs, ASCA pilot, FDA-DoD collaboration

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The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions

Medical device cybersecurity is shared responsibility across the medical device ecosystem

  • In context of total product lifecycle
  • As part of interconnected cyber — physical infrastructure among people, processes, data and information and communication technologies
  • Identify and prepare for cyber intrusions, reduce medical device vulnerabilities, mitigate patient impact, enable timely restoration of devices and systems

Applying a best-teams approach  (with Dept. of Homeland Security, FDA Medical Device Safety Action Plan, Guidances on Premarket cybersecurity)

Building strategic alliances (with MITRE, MDIC)

Fortifying long-term commitment (Center of Excellence for Digital Health)

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FDA Seeking Digital Health Advisor

Primarily serve as expert on  digital health technologies during FDA’s review and evaluation of digital health technologies

  • Review of first-of-a-kind digital health technology, precedent-setting research
  • Create preconditions and incentives informing digital health policy proposals
  • Provide advice, consultations and training
  • Assist with technology solutions to enhance CDRH internal processes

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Stakeholder Update: FDA’s 2018 Strategic Policy Roadmap

Update on priority areas to advance public health

Reduce the burden of addiction crises 

  • Address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation Read
  • Industry meetings on epidemic rates in youth e-cigarette use Read

Leverage innovation and competition to improve health care and access

  • Medical Device Ecosystem and Cybersecurity  Read
  • Authorization of first direct-to-consumer test for detecting genetic variants for medication metabolism

Read  


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Approval of Dsuvia and the FDA’s future consideration of new opioids

Dsuvia approval considerations in the context of the overall therapeutic armamentarium

  • Sublingual with restricted use in certified medically-supervised health care settings
  • Ideally suited for special circumstances where patients not able to swallow oral medication and access to intravenous pain relief is not possible
  • Potential uses on the battlefield – Department of Defense (DoD) worked closely with  sponsor on the development of opioid
  • Very tight restrictions on distribution and use with REMS
  • Quickly make regulatory adjustments if problems arise

READ


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Growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Public hearing on Dec. 5, to  focus on potential role of drug therapies to support cessation

  • Obtain input from across the medical and research fields, the pharmaceutical and tobacco industries, and public health stakeholders
  • Approaches to eliminate youth e-cigarette use
  • Exploring potential drug therapies to support youth e-cigarette cessation

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Accreditation Scheme for Conformity Assessment (ASCA)

Piloted under CDRH’s Standards and Conformity Assessment Program

  • Enhance predictability of the medical device review process
  • Reducing premarket questions on conformity activities
  • Conformance declarations
  • Increase consistency of submissions and saving FDA resources

Pilot will ensure appropriate interaction between FDA, accreditation bodies, and testing labs

READ


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FDA and DoD formalize collaboration to advance medical products in support of American military personnel

New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military

  • Evaluate how best to foster access to safe and effective medical products
  • Expedite review of priority DoD medical products
  • Provide technical  to aid rapidly  develop and manufacture medical products
  • Determine opportunities to streamline review and expedite availability
  • Authorize emergency uses of medical products to reduce deaths and severity of injuries caused by chemical, biological, radiological or nuclear (CBRN) agents

READ


Image credit: FDA