Authorizations: SYNOJOYNT, TRUETEAR Tear Neurostimulator, CURVE Positive Airway Pressure System

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SYNOJOYNT

Teva

INDICATION FOR USE: Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics (e.g., acetaminophen)

DEVICE DESCRIPTION:

  • Sterile, non‐pyrogenic, clear, viscoelastic solution of hyaluronan contained in a single‐use prefilled syringe
  • Viscous solution of sodium hyaluronate in buffered physiological sodium chloride
  • Sodium hyaluronate is a high molecular weight fraction (approximately 2.5×106 daltons) of a natural complex sugar polymer consisting of repeating disaccharide units of Na‐glucuronate‐N acetylglucosamine

EFFECTIVENESS & SAFETY:

  • Double-blind, prospective, multi-site, randomized, threearm, parallel group, n=599,  injected into the target knee of  subjects with OA, vs. placebo, 26 weeks
  •  Adaptive investigation, two interim analyses (after approximately 50% and 75% of the planned sample size), sample size reassessment as needed
  • WOMAC pain scores : -167.73 (9.32) vs.  -131.64 (9.35) in placebo group, p=0.0033
  • Statistically significant differences in the WOMAC Pain score, WOMAC Stiffness score, WOMAC Physical Function score
  • Incidence of TEAEs  similar to that of saline placebo treatment

REGULATORY PATHWAY: PMA

  • Classification: III
  • Product Code: MOZ

LABEL


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TRUETEAR Intranasal Tear Neurostimulator

Allergan

INDICATION FOR USE:  Provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms

GENERIC DEVICE TYPE:  Intranasal electrostimulation device for dry eye symptoms

  • Prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms

RISKS AND MITIGATIONS:

  • Tissue damage due to overstimulation/understimulation or mechanical injury (ex: tips too long), device breakage: Non-clinical performance testing, Software verification, validation, and hazard analysis, Electrical, thermal, and mechanical safety testing, Labeling
  • Adverse tissue reaction:Biocompatibility evaluation, Labeling
  • Infection:Labeling
  • Electrical shock or burn:Electrical, thermal, and mechanical safety testing, Software verification, validation, and hazard analysis, Labeling
  • Interference with other devices:Electromagnetic compatibility (EMC) testing
    Software verification, validation, and hazard analysis, Labeling
  • Pain, headache, or discomfort: Clinical performance testing, Non-clinical performance testing, Electrical, thermal, and mechanical safety testing, 
    Labeling
  • Failure to mitigate dry eye symptoms: Clinical performance testing, Training
    Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 886.5310
  • Regulation Name: Intranasal electrostimulation device for dry eye symptoms
  • Regulatory Class: Class II
  • Product Code: QBR

CLassification Order


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CURVE Positive Airway Pressure System

Fresca Medical

INDICATION FOR USE:  To treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg)

GENERIC DEVICE TYPE: Positive airway pressure delivery system

  • Prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface

RISKS & MITIGATIONS: 

  • Adverse tissue reaction: Biocompatibility evaluation, Labeling
  • Electromagnetic interference: Electromagnetic compatibility testing
    Labeling
  • Infection:Reprocessing validation, Labeling
  • Device software failure: Software verification, validation, hazard analysis
  • Device hardware failure/malfunction leading to high airway pressure, carbon
    dioxide rebreathing or ineffective treatment: Non-clinical performance testing
    Labeling
  • Electrical shock injury or thermal injury: Electrical safety, thermal safety, and
    mechanical testing, Software verification, validation, and hazard analysis, Labeling
  • Use error leading to ineffective therapy or patient injury: Labeling

REGULATORY PATHWAY: De Novo request

  • Regulation Number: 21 CFR 868.5273
  • Regulation Name: Positive airway pressure delivery system
  • Regulatory Class: Class II
  • Product Code: QBY

Classification Order


Image credit: Teva, Allergan, Fresca Medical

 

 

 

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News: Software Precertification Working Model, Opioid Announcement

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Software Precertification Model: A Working Model

Software Precertification Program

  • Voluntary pathway to provide more streamlined and efficient regulatory oversight of software as medical devices (SaMD)
  • From manufacturers who have demonstrated a robust culture of quality
    and organizational excellence (CQOE)
  • Committed to monitoring real-world performance

Goals

  • Tailored, pragmatic, least burdensome regulatory oversight
  • Assess – to establish trust of CQOE for high quality SaMD
  • Transparency –  across entire lifecycle of SaMD
  • Verify – continued safety, effectiveness, and performance of SaMD in real world

Outline

  • Excellence Appraisal and Precertification (Component 1)
  • Review Pathway Determination (Component 2)
  • Streamlined Premarket Review Process (Component 3)
  • Real-World Performance (Component 4)

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FDA Announcement related to opioids

FDA supports U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis

  • decreasing exposure to opioids and preventing new addiction
  • supporting treatment of those with opioid use disorder
  • fostering development of novel pain treatment therapies
  • fostering development of opioids more resistant to abuse and misuse
  • taking action against illegal importation and sale of opioids
  • evaluate how marketed opioids are used in both medical and illicit settings and take regulatory action where needed

Action against 53 websites marketing unapproved opioids More information

Patient Focused Drug Development for chronic pain More information

Approval of first generic versions of Suboxone sublingual film More information


Image credit: FDA, DHHS

Briefs: Communications for value-based care, New reimbursement model to fight antibiotic resistance, Patient Voice in regulatory decision-making, CDER organizational improvements

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New efforts to advance medical product communications to support drug competition and value-based health care

HHS blueprint proposes measures for access to underinsured or uninsured

  • Prices to reflect the value in how medicines are prescribed and the outcomes they deliver
  • Control rising spending and reduce the burden of drug costs for consumers
  • Models to tie price of drugs closely to usefulness of  clinical setting in which they are prescribed. We want to encourage competitive contracting based on measures of value that matter most to purchasers and patients, not get in the way of these competitive negotiations

FDA will provide clear guidance to pharmaceutical companies about open, responsible communication with payors, formulary committees and others

First  guidance document

  • Inform market participants developing value-based contracts
  • Communication of outcomes important to purchasers like a health plan or hospital
  • Endpoint may not be expressly described in drug’s approved labeling

Second guidance document

  • Manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling
  • Such as data from post-market studies and surveillance
  • Additional information from the pre-market studies that were used to support approval of the product

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FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Increase in serious antimicrobial drug resistant infections is critical public health concern

  • At least 2 million people become infected with bacteria that are resistant to antibiotics and 23,000 people die each year as direct result
  • Need for good antibiotic stewardship and use in appropriate clinical scenarios

In discussions with CMS, idea to change reimbursement model

  • For certain new, anti-microbial drugs that meet critical, public health needs
  • Move to licensing model – instead of paying for drugs that meet a narrow set of criteria on a per use basis
  • Acute care institutions would pay a fixed licensing fee to use a certain number of annual doses

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New agency efforts to advance the PATIENT VOICE in medical product development and FDA regulatory decision-making

Need for systematic, methodologically-sound approaches to collect patient input to  inform regulatory decision-making

New guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

  • Sampling methods for collecting patient experience – throughout the medical product lifecycle
  • How to operationalize and standardize the collection, analysis and dissemination of patient experience data

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Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

FDA Patient-Focused Drug Development Guidance Series 

  • To address, in a stepwise manner, how stakeholders can collect and submit patient experience data
  • Intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input

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Proposed modernization of FDA’s drug review office

CDER undertaking steps to modernize the organization and functions of  Office of New Drugs

  • Elevate role of scientists and medical officers to take on even more thought leadership
  • More time, better tools and greater support to advance the clinical and regulatory principles
  • Develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect latest science

Allow review staff to have more time for reviewing and providing feedback to sponsors

  • Engage sponsors earlier in the development process
  • Ensure trial designs are efficient and  effectively structured for benefit/risk assessment
  • Ability to engage external stakeholders, such as disease specialists, academic researchers and regulatory partners at other agencies
  • Ongoing relationships and interactions with patient groups
  • Creating many new therapeutic-specific divisions to engage in discrete areas of medicine

Improve FDA review process

  • Integration around a common review process, common review template
  • Integrated across  discrete areas of science and regulatory expertise
  • Better organization of review process and development of key review memos

New alignment and processes will improve efficiency by 20% at a minimum overall

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Image credit: FDA

 

Authorizations: DOPTELET, OSTEODETECT AI for Fractures, CUSTOMFLEX Artificial Iris

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DOPTELET (avatrombopag) 

 AkaRx Inc.

INDICATION:  Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

ADDRESSING UNMET NEED:

  • Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding
  • Doptelet safely increases platelet count; may decrease or eliminate platelet transfusions

MECHANISM OF ACTION:  Thrombopoietin (TPO) receptor agonist stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets

EFFICACY:

  • Two multicenter, randomized, double-blind, placebo-controlled trials, n= 435, patients with chronic liver disease and severe thrombocytopenia
  • Major efficacy outcome: Proportion of patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following an elective procedure.
  • Higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy with Doptelet

SAFETY:

  • Most common side effects: Fever, stomach (abdominal) pain, nausea, headache, fatigue and swelling in the hands or feet (edema);  increased risk of developing blood clots when taking Doptelet

REGULATORY PATHWAY: NDA

  • Priority review
  • Postmarketing required pediatric assessmenrs

LABEL


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OSTEODETECT 

Imagen

INDICATION FOR USE: OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists

ADDRESSING UNMET NEED:

  • AI algorithms have tremendous potential to help health care providers diagnose and treat medical conditions
  • Software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures

GENERIC DEVICE TYPE: Radiological Computer Assisted Detection and Diagnosis Software

  • Image processing device intended to aid in the detection, localization, and characterization of fracture, lesions, or other disease specific findings on acquired medical images (e.g. radiography, MR, CT)
  • Detects, identifies and characterizes findings based on features or information extracted from images, and provides information about the presence, location, and characteristics of the findings to the user
  • Analysis is intended to inform the primary diagnostic and patient management decisions that are made by the clinical user
  • Not intended as a replacement for a complete clinician’s review or their clinical judgment that takes into account other relevant information from the image or patient history

EFFECTIVENESS & SAFETY:

  • Retrospective study of 1,000 radiograph images that assessed the independent performance of the image analysis algorithm for detecting wrist fractures and the accuracy of the fracture localization of OsteoDetect against the performance of three board certified orthopedic hand surgeons
  • Retrospective study of 24 providers who reviewed 200 patient cases
  • Readers’ performance in detecting wrist fractures was improved using the software, including increased sensitivity, specificity, positive and negative predictive values vs. standard clinical practice

REGULATORY PATHWAY: De Novo

  • Regulation Number: 21 CFR 892.2090
  • Regulation Name: Radiological Computer Assisted Detection and Diagnosis Software
  • Regulatory Class: Class II
  • Product Code: QBS

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CUSTOMFLEX  Artificial Iris

HumanOptics AG

INDICATION FOR USE:  Iris prosthesis for the treatment of iris defects. The CustomFlex™ Artificial Iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia

ADDRESSING UNMET NEED:

  • Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent
  • Affects approximately 1 in 50,000 to 100,000 people in the U.S.
  • CustomFlex Artificial Iris is indicated to treat iris defects due aniridia, other reasons or conditions, such as albinism, traumatic injury or surgical removal due to melanoma

DEVICE DESCRIPTION: 

  • Foldable iris prosthesis custom-made for each individual patient
  • Manufactured from a commercially available ophthalmic silicone
  • Colorized silicone paste is applied by hand in a pattern to match the color of the natural iris using a photograph of the existing iris or, in the case of aniridia, the color of the photograph selected by the patient
  • Surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments
  • Prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures

EFFECTIVENESS & SAFETY:

  • Non-randomized clinical trial, n=389 adult and pediatric patients with aniridia or other iris defects
  • Primary Endpoint: Self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis
  • >70 % reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure
  • 94% satisfied with the artificial iris’ appearance
  • Low rates of adverse events: Device movement or dislocation, strands of device fiber in the eye, increased intraocular pressure, inflammation of the iris (iritis), adhesion of the iris to the cornea or lens (synechiae) and the need for secondary surgery to reposition, remove or replace the device

REGULATORY PATHWAY: PMA

  • Breakthrough device designation

LABEL


Image credits:  AkaRx Inc., Imagen, HumanOptics AG

 

 

FDA news: Right to Try Act, Shared System REMS, Innovation Challenge for Devices targeting Abuse, Software Functions excluded as Devices, Liver Toxicity Understanding, Sunscreen Effectiveness

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

May 30th: President signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act)

  • FDA to implement legislation to promote access and protect patients
  • Patients facing terminal conditions have an additional avenue to access promising investigational medicines
  • Will build on FDA’s exisiting Expanded Access program that enhances access to promising investigational medicines for those unable to access products through clinical trials
  • Will recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances

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New policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry

Risk Evaluation and Mitigation Strategy (REMS) requirements have been exploited to block timely generic entry

  • At the front end of the drug development process- Restrict availability of branded drugs needed to run bioequivalence studies for generic drugs
  • At the back end of the process for drug approval and marketing – Delayed agreements for generics to enter branded drug Shared System REMS

New policy to help generic drug makers maintain safety controls sought by REMS

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As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

FDA working to address opioid crisis and support goals of  U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis

  • Significant focus on decreasing exposure to opioids and preventing new addiction
  • Supporting treatment of those with opioid use disorder
  • Fostering development of novel pain treatment therapies and opioids more resistant to abuse and misuse
  • Taking action against those who contribute to the illegal importation and sale of opioid products

Innovation challenge to encourage medical product developers to submit proposals

  • Diagnostics to identify patients at increased risk for addiction
  • Treatments for pain that eliminate the need for opioid analgesics
  • Treatments for opioid use disorder or symptoms of opioid withdrawal
  • Devices or technologies that can prevent diversion of prescription opioids
  • Devices with improved benefit-risk profile vs.  opioids in pain management

Benefits for accepted proposals

  • Enhanced interactions with FDA review divisions during development and evaluation
  • Breakthrough Device designation granted

Deadline: June 1 – Sept. 30, 2018

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Capture.JPGFDA seeking comments on risks and benefits to health associated with software functions excluded from the device definition by the Cures Act

Per the Cures Act, certain medical software functions are not medical devices

  • for administrative support of a health care facility
  • for maintaining or encouraging a healthy lifestyle
  • to serve as electronic patient records
  • for transferring, storing, converting formats, or displaying data
  • to provide limited clinical decision support

FDA requesting input on risks and benefits  with these non-device software functions

  • From all interested parties, including patients, consumers, healthcare providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small business purchasers, employers, and other stakeholders
  • FDA will incorporate input to develop report on risks and benefits of these software functions

submit your comments


Capture.JPGNCTR… Improving Understanding of Liver Toxicity

  • Role of Cytochromes in Dronedarone-Induced Liver Toxicity
  • Therapeutic Bile Acids and the Risks for Liver Toxicity
  • Monograph Published on Drug-Induced Liver Toxicity
  • Early and Sensitive Biomarkers of Liver Toxicity Discovered

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New FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Most cases of melanoma can be attributed to cumulative UV exposure

  • Policy efforts to promote innovation in sunscreen (Sunscreen Innovation Act)
  • Help promote product innovation when it comes to better sunscreens

New efforts to advance framework for sun protection products

  • Making sure that products deliver advertised benefits
  • Warning letters to companies illegally marketing pills and capsules labeled as dietary supplements with unproven claims about protection from sun exposure harm
  • Encouraging industry to conduct research on additional sunscreen active ingredients to enhance safety
  • New FDA process to review the safety and effectiveness of sunscreen active ingredients
  • New draft guidance regarding Maximal Usage Trials (MUsT) for topically-applied active ingredients

VIDEO

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Image credits: Congress, FDA