The Pink Sheet | Drug Manufacturers Beg US FDA to Inspect Facilities, but Still Find Difficulties

Cathy Burgess comments on how the U.S. Food and Drug Administration is likely to use remote evaluations to resolve as many issues as possible before returning to onsite inspections of facilities.

Cathy Burgess is quoted on how the Food and Drug Administration might conduct remote inspections of drug manufacturing facilities amid COVID-19.

Cathy Burgess is quoted on how the U.S. FDA’s Center for Drug Evaluation and Research could potentially handle the expiration of COVID-19-related emergency use authorizations it has issued for drug products.

Our FDA Team examines the new Executive Order for promoting domestic production of critical medicines and the Food and Drug Administration’s announcement of expanding the use of surprise inspections at foreign manufacturing facilities.

Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have developed an initial checklist for providers to consider during the FDA’s enforcement discretion period.