News and Views: Digital Health Innovation, Development of New Antibacterial Drugs, Opioid REMS, Civil Money Penalties Related to ClinicalTrials.gov

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Efforts to work with tech industry to spur innovation in digital health

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Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria

Bacterial drug resistance is major threat to public health
  • Design and conduct of clinical trials to evaluate new antibacterial drugs challenging
  • Recruitment can be difficult
  • Delay in availability of information regarding identification and antibacterial susceptibility of the causal pathogen
Request for Information (RFI) to solicit input from public and private sectors into developing regulatory science initiatives specific for antimicrobial products

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Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Approval of final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

  • Several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals
  • Applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting
  • Also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012

New requirements

  • Training for health care providers who are involved in the management of patients with pain, and not only to prescribers
  • Education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain
  • New product labeling containing information about the health care provider education

New FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint)

  • Updated educational content
  • Ensure proper product is selected for the patient and used with appropriate clinical oversight

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Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Describes civil money penalties against responsible parties and/or submitters on submission of regiatration and /or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA

  • How do the Centers intend to identify whether
    • responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank
    • Submitted false or misleading information to the data bank
    • Failed to submit to FDA the certification
  • Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
  • What procedures apply when a Center seeks civil money penalties?
  • What civil money penalty amounts may be assessed

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Image credit: FDA

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Market Authorizations: APPLE ECG App, APPLE Irregular Rhythm Notification Feature, LUMOXITI, PK Papyrus System, AJOVY

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ECG App

Apple

INDICATION FOR USE: 

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG.

The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.

The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

GENERIC TYPE OF DEVICE: Electrocardiograph software for over-the-counter use

Creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis

IDENTIFIED RISKS/MITGATION MEASURES:

  • Poor quality ECG signal resulting in failure to detect arrhythmia: Clinical performance testing, Human factors testing, Labeling
  • Misinterpretation and/or over-reliance on device output, leading to:  Failure to seek treatment despite acute symptoms, Discontinuing or modifying treatment for chronic heart condition: Human factors testing, Labeling 
  • False negative resulting in failure to identify arrhythmia and delay of further evaluation or treatment: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling
  • False positive resulting in additional unnecessary medical procedures: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling

REGULATORY PATHWAY: De Novo request

  • Trade/Device Name: ECG App
  • Regulation Number: 21 CFR 870.2345
  • Regulation Name: Electrocardiograph software for over-the-counter use
  • Regulatory Class: Class II
  • Product Code: QDA

CLASSIFICATION ORDER


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Irregular Rhythm Notification Feature

Apple

INDICATION FOR USE:  software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user.

The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.

The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

GENERIC TYPE OF DEVICE: Photoplethysmograph analysis software for over-the-counter use.

Analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

IDENTIFIED RISKS/MITGATION MEASURES:

  • Poor quality incoming PPG signal resulting in failure to detect irregular heart rhythms: Clinical performance testing, Human factors testing, Labeling
  • Misinterpretation and/or over-reliance on device output, leading to: Failure to seek treatment despite acute symptoms (e.g., fluttering sensation in the chest,  lightheadedness, and irregular pulse), Discontinuing or modifying treatment for
    chronic heart condition: Human factors testing, Labeling
  • False negative resulting in failure to detect irregular heart rhythms and delay of further evaluation or treatment: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling
  • False positive resulting in additional unnecessary medical procedures: Clinical performance testing, Software verification, validation, and hazard analysis
    Non-clinical performance testing, Labeling

REGULATORY PATHWAY: De Novo request

  • Trade/Device Name: Irregular Rhythm Notification Feature
  • Regulation Number: 21 CFR 870.2790
  • Regulation Name: Photoplethysmograph analysis software for over-the-counter use
  • Regulatory Class: Class II
  • Product Code: QDB

CLASSIFICATION ORDER


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LUMOXITI (moxetumomab pasudotox-tdfk) for injection

AstraZeneca

INDICATION: Treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

ADDRESSING UNMET NEED:

  • HCL is a rare, slow-growing cancer of the blood
  • Approval fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies
  • Result of important research conducted by the National Cancer Institute

MECHANISM OF ACTION: CD22-directed cytotoxin, results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death

EFFICACY:

  • Single-arm, open-label clinical trial, n=80 patients who had received prior treatment for HCL with at least two systemic therapies
  • Endpoints: Blinded independent review committee (IRC)-assessed Durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR
  • Durable CR: 30%,
  • Overall response rate: 75%

SAFETY:

  • Most common non-laboratory adverse reactions: Infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea
  • Most common grade 3 or 4 adverse reactions: Hypertension, febrile neutropenia, and hemolytic uremic syndrome (HUS)

REGULATORY PATHWAY: BLA

  • Orphan, fast track and priority review designations
  • Postmarketing requirements: Safety  in patient who are 65 years of age and older and  in patients who have moderate renal impairment

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PK Papyrus System 

Biotronik

INDICATION FOR USE: Treat acute coronary artery perforations, or tears in the blood vessels of the heart

ADDRESSING UNMET NEED: 

  • Acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures
  • First device approved by the FDA for this indication in 17 years

DEVICE DESCRIPTION:

  • Balloon-expandable covered coronary stent and delivery system
  • Advanced into the perforated coronary artery vessel using a balloon catheter
  • Once  implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle
  • Successful sealing can be a life-saving procedure without the need for open-heart surgery

EFFECTIVENESS & SAFETY:

  • Real-world survey data, n=80 patients who received PK Papyrus Stents to treat coronary artery perforations
  • Successfully delivered to the perforation site: 95%
  • Successfully sealed the perforation: 73%
  • Deaths: Two, occurred during the PCI procedure, post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents and one patient in which the PK Papyrus Stent did not successfully seal the perforation

REGULATORY PATHWAY: Humanitarian Device Exemption

  •  Intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year
  • Classification Name: Coronary covered stent
  • Product Code: NIV

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AJOVY (fremanezumab-vfrm) injection

Teva

INDICATION: Preventive treatment of migraine in adults

ADDRESSING UNMET NEED: Second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks

EFFICACY:

  • Two multicenter, randomized, 3-month, double-blind, placebo-controlled studies, n=875, 1130
  • Primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period
  • Statistically significant improvement vs placebo

SAFETY:

  • The most common adverse reactions (≥5% and greater than placebo) were
    injection site reactions

REGULATORY PATHWAY: BLA

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Image credit: Apple, AstraZeneca, Biotronik, Teva

News and Views: Breast implant safety, E-Cig epidemic, Device submissions in eformat, Voluntary consensus standards for devices

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Agency’s commitment to studying breast implant safety

FDA has worked over decades  to monitor, assess and take action to protect patients with regard to breast implant safety

  • Communicated risks such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • However, disagree with claims of increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma

Streamlining and modernizing postmarket actions to address device safety issues 

  • Coordinated with American Society of Plastic Surgeons and Plastic Surgeons Foundation to develop Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology
  • Development of the National Breast Implant Registry
  • Meet with patient advocacy group focused on breast implant related issues
  • Public meeting of the General and Plastic Surgery Devices Panel of our Medical Devices Advisory Committee in 2019

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New steps to address epidemic of youth e-cigarette use

Didn’t predict epidemic of e-cigarette use among teenagers

  • Disturbing and accelerating trajectory of use in youth, and resulting addiction
  • Launched Youth Tobacco Prevention Plan earlier this year.

Series of compliance actions over the past year

  • In partnership with Federal Trade Commission, targeted misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and cookies
  • Warning letters and civil monetary penalties to JUUL
  • >1000 warning letters to stores for illegal sale of e-cigarettes to minors
  • Re-examining the enforcement discretion currently exercised for other e-cig products currently on the market without authorization

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Medical Device Submissions in Electronic Format

Proposed rule for medical device premarket submissions to be sent in electronic format, eliminating the need for multiple paper submissions

  • To improve efficiency of premarket submission program

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Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions

  • Provide clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards

Overview:

  • Use of Consensus Standards
    • Use of Declarations of Conformity
    • General Use of Consensus Standards
  • Managing Product Development When Standards Change: Transition Periods
    • Where to Find Information on a Transition Period .
    • When Standards Change Prior to Review of a Premarket Submission .
    • When Standards Change During Active Review of a Premarket Submission
    • Transition Period Expiration
  • Promissory Statements
  • Limitations of Consensus Standards
  • When Devices or Standards Change After Marketing Authorization

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Image credits: FDA

Market Authorizations: BRAINSWAY Stimulation System, ABBOTT RealTime IDH1, TAKHZYRO, OXERVATE, DIACOMIT

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BRAINSWAY Deep Transcranial Magnetic Stimulation System

Brainsway Ltd.

INDICATION FOR USE: Adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder

ADDRESSING UNMET NEED: 

  • Transcranial magnetic stimulation has potential to help patients suffering from depression and headaches
  • Another option for patients with OCD who have not responded to traditional treatments

GENERIC DEVICE TYPE: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions

  • Prescription, non-implantable device that uses brief duration, rapidly alternating,
    or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.

EFFECTIVENESS & SAFETY: 

  • Multi-center study, n=100 patients receiving OCD treatments (medical management), Brainsway device vs. non-working (sham) device
  • Effectiveness endpoint: Reduction in Yale-Brown Obsessive Compulsive Scale (YBOCS) score; 38% on Brainsway with > 30% reduction vs. 11%
  • Adverse reactions: Headache,  application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching, and neck pain

IDENTIFIED RISKS & MITIGATION MEASURES:

  • Seizure, Thermal injury, Hearing loss, Scalp discomfort, dizziness, nausea, pain in neck or jaw, headache, or other adverse effects due to treatment, Adverse tissue reaction, Electrical shock,  Device failure due to interference with other devices
  • Non-clinical performance testing, Labeling, Thermal safety testing, Electrical safety testing, Electromagnetic compatibility testing, Software verification, validation, and hazard analysis, Biocompatibility evaluation

REGULATORY PATHWAY: De Novo request

  • Prior approvals in treatment for major depression (2008) and treating pain associated with certain migraine headaches (2013)
  • Regulation Number: 21 CFR 882.5802
  • Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions
  • Regulatory Class: Class II
  • Product Code: QCI

CLASSIFICATION ORDER


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Abbott RealTime IDH1

Abbott Molecular Inc.

INDICATION FOR USE:  In vitro polymerase chain reaction (PCR) assay for the qualitative detection of single nucleotide variants (SNVs) coding five IDH1 R132 mutations (R132C, R132H, R132G, R132S, and R132L) in DNA extracted from human blood (EDTA) or bone marrow (EDTA). Abbott RealTime IDH1 is for use with the Abbott m2000rt System.

Abbott RealTime IDH1 is indicated as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO® (ivosidenib).

This test is for prescription use only.

COMPONENTS:  

  • Abbott RealTime IDH1 Amplification Reagent Kit
  • Abbott RealTime IDH1 Control Kit
  • Abbott mSample Preparation SystemDNA Kit
  • . Abbott RealTime IDH1 m2000rt Application CD-ROM

EFFECTIVENESS:

  • Accurate qualitative detection of single nucleotide variants (SNVs) coding five IDH1 mutations (R132C, R132H, R132G, R132S and R132L) in DNA extracted from human bone marrow or blood in patients with relapsed or refractory AML
  • Open-label, single-arm, international, multicenter clinical trial of TIBSOVO (ivosidenib), n=174 adult patients with relapsed or refractory AML and one of 5 IDH1 mutations in codon R132 detected by Abbott RealTime IDH1 assay
  • 32.8% exhibited complete remission or complete remission with partial hematological recovery

SAFETY:

  • Potential mismanagement of patients resulting from false results
  • Failure to perform as expected or failure to correctly interpret test results
  • False positive test result may lead to TIBSOVO treatment in patient who is not expected to benefit, and suffer from any potential adverse side effects
  • False negative test result may lead to TIBSOVO (ivosidenib) treatment not being administered to a patient who may benefit from this drug

REGULATORY PATHWAY: PMA, Device Procode: OWD

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TAKHZYRO (lanadelumab-flyo) injection, for subcutaneous use

Dyax Corporation

INDICATION:  For prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older.

ADDRESSING UNMET NEED:

  • First monoclonal antibody approved to treat patients 12 years and older with types I and II HAE
  • HAE is rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins; recurrent, unpredictable episodes of severe swelling in different areas of the body

MECHANISM OF ACTION:  Fully human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein (uncontrollably increased in HAE) and inhibits proteolytic activity which prevents angioedema attacks

EFFICACY:

  • Multicenter, randomized, double-blind, placebo-controlled, parallel-group study, n=125 patients with HAE
  • Takhzyro caused clinically meaningful and statistically significant reductions in the rate of investigator-confirmed HAE attacks vs. placebo over 6-month treatment period

SAFETY: 

  • Most common adverse drug reactions: Injection site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness and diarrhea.

REGULATORY PATHWAY: BLA

  • Priority Review, Breakthrough Therapy designation, Orphan Drug designation
  • Postmarketing commitment: Low endotoxin recovery (LER) study

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OXERVATE (cenegermin-bkbj) ophthalmic solution for topical
ophthalmic use 

Dompé farmaceutici SpA.

INDICATION: Treatment of neurotrophic keratitis

ADDRESSING UNMET NEED:

  • First approved drug for neurotrophic keratitis, a rare degenerative disease affecting cornea
  • Loss of corneal sensation impairs corneal health and damage- corneal thinning, ulceration, and perforation in severe cases
  • Prevalence estimated to be less than five in 10,000 individuals

MECHANISM OF ACTION: Nerve growth factor is an endogenous protein involved in differentiation and maintenance of neurons which acts through nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity

EFFICACY:

  • Two, eight-week, randomized controlled multi-center, double-masked studies. n= 151 patients with neurotrophic keratitis
  • Across both studies, complete corneal healing in eight weeks was demonstrated in 70% of patients treated with Oxervate (containing cenegermin) vs. 28% treated without cenegermin

SAFETY:

  • Most common adverse reactions: Eye pain, ocular hyperemia, eye inflammation and increased lacrimation (wat

REGULATORY PATHWAY: BLA

  • Priority Review, Orphan Drug Designation
  • Postmarketing commitments:  Clinical study to determine systemic exposure following repeated topical ocular dosing, manufacturing and shipping validations

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DIACOMIT (stiripentol) capsules and powder, for oral suspension

Biocodex

INDICATION: Treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam.

There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

ADDRESSING UNMET NEED: 
  • Treatment option for rare genetic condition leading ot seizures from first year of life

MECHANISM OF ACTION: Possible mechanisms include direct effects mediated through gamma-aminobutyric acid (GABA)A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and active metabolite.

EFFICACY:
  • 2 multicenter placebo-controlled double-blind randomized studies, patients with Dravet syndrome inadequately controlled on clobazam and valproate, DIACOMIT vs placebo, n=64
  • Primary efficacy endpoint: Responder rate- patient who experienced > 50% decrease in frequency (per 30 days) of generalized clonic or tonic-clonic seizures
  • In both studies, responder rate significantly greater for DIACOMIT vs. placebo
SAFETY: 
  • Most common side effects: Somnolence, decreased appetite, agitation, ataxia, weight loss, hypotonia, nausea, tremor, dysarthria, insomnia
  • Must be dispensed with Medication Guide

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Image credits: Brainsway, Abbott, Dyax, Dompé, Biocodex 

News and Views: Global Efforts for Product Quality, FDA-Payor Program, Uncertainty in Benefit-Risk  Determinations, 510(k) “Quik” Program

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Global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA framework to help assure that all drug products meet the same high-quality standards, regardless of where they’re manufactured, brand or generic products, prescription or over-the-counter drugs

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Capture.JPGNew Program with Payors Aims to Accelerate Patient Access to Medical Devices

FDA recognizes importance of working collaboratively with payor community to streamline the path from FDA market authorization to payor coverage and reimbursement.

Parallel Review Program: Piloted in 2011, fully adopted in 2016. Mechanism for decreasing time between FDA’s approval of a pre-market medical device application and CMS national coverage determination

  • Early feedback from the FDA and CMS on design of pivotal clinical trial in Pre-Submission Mtg
  • 75 inquiries into the process and 36 formal applications to participate in Parallel Review

Private Payor Program: Launched in 2016

  • Receive feedback from  FDA and other non-governmental health technology assessors/payors during the Pre-Submission mtg
  • Participants:  BlueCross BlueShield Association, Duke Evidence Synthesis Group, ECRI Institute, Humana, Kaiser Permanente, and the National Institute for Health and Care Excellence (NICE)
  • New Additions: CareFirst BlueCross BlueShield and United Health Group
  • 4 Pre-Submission mtgs with private payors
  • Program continues to gain momentum receiving new inquiries weekly

Payor engagement strategy particularly beneficial for manufacturers creating new and innovative devices 

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Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

Principles in guidance apply to FDA’s consideration of uncertainty in benefit-risk determinations for PMAs, De Novo requests, and HDE applications. Factors include:

  • Extent of probable benefits including the type, magnitude, probability, duration, frequency
  • Extent of probable risks including the severity, type, number, rates, probability,  duration
  • Extent of uncertainty regarding the benefit-risk profile of alternative treatments
  • Patients’ perspective on appropriate uncertainty about probable benefits and risks
  • Extent of the public health need (e.g., seriousness of the illness)
  • Feasibility of generating extensive clinical evidence premarket
  • Ability to reduce or resolve remaining uncertainty  postmarket
  • Likely effectiveness of postmarket mitigations, such as labeling
  • Type of decision being made
  • Probable benefits of earlier patient access to the device

Examples provided

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Quality in 510(k) “Quik” Review Program Pilot

Launch of Quality in 510(k) (“Quik”) Review Program pilot

  • Simplify completion of  premarket notification (510(k)) submission for sertain moderate risk devices
  • Use free eSubmitter software for review efficiency
  • Not be subject to a Refuse to Accept (RTA) review; FDA interactive review and decision within 60 days
  • Does not change any requirements for the determination of substantial equivalence

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Image credits: FDA, CMS

 

 

 

News & Views: Forcefully addressing Opioid Crisis, Complex Innovative Trial Designs, Initiatives to Modernize for Innovation

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Agency’s ongoing work to forcefully address the opioid crisis

FDA addressing opioid crisis forcefully

  • Cut the rate of new addiction
  • Stepped up enforcement of marketing and sale of illicit opioids
  • Novel product innovation for opioid addiction treatment, non-addictive pain treatments
  • New Opioid Policy Steering Committee

Progress

  • Extension of risk evaluation and mitigation strategy program for immediate release formulations of opioid drugs
  • Broad effort to develop evidence-based guidelines for opioid prescribing
  • Protect children from unnecessary exposure to certain opioids in prescription cough and cold medicines
  • Requested market withdrawal of Opana ER based on risks that manifest only when  misused and abused
  • Enforcement actions collaboration with the Federal Trade Commission on unapproved product websites
  • Sharply expanded oversight of drugs being shipped illegally through international mail facilities
  • Expanded new pathways for the development of safe and effective treatments for addiction
  • New regulatory guidance to promote abuse-deterrent formulations of opioid drugs
  • Innovation challenge for medical devices and mobile applications as alternatives to oral opioids
  • Public meetings on Opioid Use Disorder and on Chronic Pain

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Complex Innovative Trial Designs Pilot Program

Goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs

  • Pilot program offers sponsors increased FDA interaction to discuss proposed  CID approach

Goals

  • Use of CID approaches in late-stage drug development
  • Publicly discuss trial designs to promote innovation

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Capture.JPGFDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation

Innovating new operating system to meet FDA goal for medical care – right drug or device delivered to right patient at right time

  1. Modernizing Clinical Trials for Drugs and Devices
  2. Modernizing FDA’s Organization and Breaking Down Outdated Silos
  3. Harnessing Real World Evidence
  4. FDA’s Role in Curating Standards for Novel Technologies

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Image credit: FDA