The Pink Sheet | US FDA to Lose Another COVID-19 Response Leader with Anand Shah’s Resignation

Marc Scheineson comments on what the Food and Drug Administration’s emergency use authorization update for COVID-19 drug Paxlovid could mean for other therapies.

Marc Scheineson is quoted on the newly assigned leadership roles at the U.S. Food and Drug Administration for facilitating the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

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.

Marc Scheineson comments on President Biden’s nomination of Robert for a second term as commissioner of the U.S. Food and Drug Administration.

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