transactional due diligence
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.