transactional due diligence
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
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.