January 2021 – Drug and Device Digest

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



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



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    


Hand Sanitizer Safety and Use Communication Toolkit

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


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


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


Image credit: FDA

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