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NEW FDA RULES & POLICIES IN EFFECT DURING COVID EMERGENCY PERIOD 
UPDATED, REVISED AND CLARIFIED ON AN ONGOING BASIS

The FDA has suspended and fast-tracked dozens of approval, import, manufacturing and other requirements in order to facilitate development of drugs and devices that may diagnose, treat or prevent Coronavirus Disease. These emergency measures are updated, revised and clarified continually as conditions change.  

The FDA has also eased restrictions on many non-Coronavirus-related products to facilitate commerce and focus government resources on the pandemic.

  • Emergency Use Authorizations (EUAs) for PPE, test kits, ventilators and respirators

  • Enforcement discretion for the sale and manufacture of hand sanitizer and other preventive measures 

  • Emergency Enforcement Policies issued for dozens of products

  • import labeling instructions to ease CBP border inspection

  • Suspension of registration, listing and GMP requirements

  • Marketing authorization for new, unapproved and expired products

  • Humanitarian Expanded Access for drugs, medical devices and vaccines

  • Clinical trial and inspection waivers

A partial list of policy revisions can be found at FDA's website here.

Contact FDA Regulatory Counsel to determine what products qualify for COVID emergency measures, what conditions apply, and how to fast-track to market.

Stay well and be safe.

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© 2020  by FDA Regulatory Counsel LLP

DISCLAIMER

This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.