Coronavirus Pandemic 

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FDA ISSUES NEW RULES FOR COVID AND NON-COVID REGULATORY COMPLIANCE

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Effective immediately, FDA has temporarily suspended certain compliance requirements. The goals are to:

• Accelerate and simplify the testing and commercialization of products that may diagnose, treat or prevent Coronavirus

• Ease certain requirements on regulated non-Coronovirus companies/products to facilitate commerce and allow FDA to focus resources on the Pandemic

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Examples:

• Emergency Use Authorizations

• New labeling to fast-track imports through CPB

• Suspension of certain GMP requirements

• Marketing authorization for unapproved products/uses based on foreign government approval

• Humanitarian Expanded Access for drugs and medical devices

• Clinical trial waivers

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A partial list of policy revisions can be found here.

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FDA Regulatory Counsel is now operating 24/7 to help new and current clients navigate the changes.

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*3/28/2020  NEW - We have increased firm capacity for due diligence of commercial transactions facilitating healthcare/life science lending and investing during this time.