COVID-19 News: Acting FDA Commissioner, Moderna vaccine and other FAQs, Vaccine distribution tool, Hand sanitizer safety and use, Authorized tests and collection kits, Fraudulent products

Janet Woodcock was named Acting Commissioner of FDA

Will oversee the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws

  • Safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices
  • Safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation
  • Regulation of tobacco products

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COVID-19 FAQs

Moderna vaccine : EUA issued on Dec 18, 2020

  • Data supporting EUA
  • Vaccine effectiveness and safety
  • Results in racial, high risk ethnic groups, breastfeeding women
  • Side effects, allergic reactions, reporting of side effects and additional safety monitoring
  • Interchangeability with Pfizer-BioNTech vaccine

Other topics

  • Hand sanitizers
  • Testing
  • Medical glove 
  • Surgical mask and gown shortage
  • 3D Printing of Medical Devices & Parts
  • Ventilators
  • Manufacturing, Supply Chain, and Drug Inspections
  • Food Safety
  • Animal Food Safety
  • Face Mask and Surgical Mask

VACCINE FAQs

OTHER FAQs

21 FORWARD for Vaccine Distribution to Food and Agriculture Workers

New data analysis tool, 21 FORWARD, to identify food supply interruptions can be used for planning vaccine distribution

  • Will augment other data sources on food and agriculture workers
  • Will provide state and local officials with information to help determine count and location of food and agriculture workers    

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Hand Sanitizer Safety and Use Communication Toolkit

FDA communication materials for consumers, patients, and health care professionals to help increase hand sanitizer safety

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Authorized COVID-19 Tests and Collection Kits

 To date, the FDA has authorized 309 tests and sample collection devices

  • 235 molecular tests and sample collection devices
  • 63 antibody tests
  • 11 antigen tests
  • Tests that can be used in laboratories, in doctors’ offices and at home

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Fraudulent Coronavirus Disease 2019 (COVID-19) Products

Enforcement actions against firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19

  • Actively monitoring for firms marketing products with fraudulent COVID-19 prevention and treatment claims
  • To protect consumers from firms selling unapproved products and making false or misleading claims
  • Warning letters, seizures, injunctions or criminal prosecutions for violating the law

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Image credit: FDA

2021 FDA Vision: Regulatory science focus areas, AI/ML action plan, Advanced manufacturing, 2020 drug approval learnings, Device regulatory flexibility

2021: Focus Areas of Regulatory Science (FARS)

Four focus areas for regulatory science research for innovative products, to inform regulatory decision-making and improve sponsor guidance to sponsors

  • Public Health Preparedness and Response: Medical countermeasures and preparedness, Reduce pathogen contamination, Substance Use disorders, Antimicrobial resistance, Food safety, Compounded drugs
  • Increasing Choice and Competition through Innovation: Individualized therapeutics and Precision Medicine, Complex innovative trial design, Microbiome research, Novel foods and food ingredients, Regenerative medicine, Advanced manufacturing, Generic alternatives for complex drugs, Product Development Tools
  • Unleashing the Power of Data: Product safety surveillance, Diverse data and technologies (AI, digital health, real-world evidence
  • Empowering Patients and Consumers: Preferences and perspectives, PROS and COAs, make better-informed decisions

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Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

Total product lifecycle-based regulatory oversight to deliver safe and effective software functionality for AI/ML-based SaMD

  • Update proposed framework for AI/ML-based SaMD, including through issuance of draft guidance on the Predetermined Change Control Plan
  • Encourage harmonization of Good Machine Learning Practice (GMLP) development
  • Hold public workshop on device labeling to support transparency to users and enhances trust in AI/ML-based devices
  • Develop methodology for evaluation and improvement of ML algorithms, including identification and elimination of bias, evaluation and promotion of algorithm robustness
  • Piloting Real-World Performance (RWP) process for AI/ML-based SaMD

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Advanced Manufacturing Technologies

Importance of regulatory programs for advancing manufacturing, computational modeling, and other emerging technologies

  •  New collaboration with the National Institute of Standards and Technology (NIST)  to increase U.S. medical supply chain resilience and manufacturing of drugs, biological products, medical devices through adoption of 21st century manufacturing technologies
  •  New initiatives for advanced manufacturing : CDER Emerging Technology Program, CDRH Case for Quality, CBER Advanced Technologies Program

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Learnings from 2020 New Drug Therapy Approvals

Meeting challenges to respond to the COVID-19 pandemic while bringing safe and effective new drug therapies for a range of other diseases and conditions

  • Innovation across different medical conditions:  Infectious diseases, Neurological advances, Heart, blood, kidney, and endocrine disease advances, Autoimmune conditions, wide array of cancers
  • New therapies for rare diseases: Including ebola and rare cancers
  • Review efficiencies: Meeting PDUFA goals, first cycle approvals, expedited programs

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Medical Device Regulatory Flexibility

Medical device enforcement policies responsive to public health emergency (PHE)

  • Review of products relevant to PHE
  • Review of MAUDE database for adverse events reports related to use during pandemic
  • Based on de minimis number of adverse events, immediately exempting 7 devices from the premarket notification requirement, and proposal to exempt an additional 84 devices after public comment is closed

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Image credit: FDA