The Pink Sheet | US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals as Pandemic Persists

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do today to leverage their current capabilities for success.

Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA). Based in the firm’s Washington, D.C. office, Marzelli joins Alston & Bird’s Health Care and FDA/Food, Drug & Device Groups, where she will advise clients on the FDA’s complex approval process and regulatory compliance for prescription and over-the-counter drugs, biologics, medical devices, food ingredients, and other products regulated by the agency.

President Biden announced exceeding 200 million COVID-19 vaccine shots. The FDA and CDC decided to resume the use of J&J’s vaccine, and the FDA finished its inspection of the Emergent Baltimore site with nine observations. Read the details in the COVID-19 Medical Products Supply Chain Week in Review.

Cathy Burgess is quoted on COVID-19 safety considerations for Food and Drug Administration inspections.

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