transactional due diligence

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

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

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

A partial list of policy revisions can be found here.

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

*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.

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© 2019  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.