Associated Press | FDA Allows for ‘Emergency Use’ of Remdesivir, Experimental Coronavirus Drug

OSHA withdrew its emergency temporary standard, which required a mandatory vaccination policy for large private employers. The FDA extended its pause on non-mission-critical domestic surveillance inspections to February 4, and the Biden Administration announced that it was making at-home test kits available to the American public. Robert Califf previewed his priorities, if confirmed as commissioner of the FDA, to the Senate HELP Committee. See details for these and other supply chain developments in the Medical Products Supply Chain Week in Review.

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.

Cathy Burgess is quoted on the dramatic decline in the Food and Drug Administration’s foreign inspections amid COVID-19.

Cathy Burgess, partner in Alston & Bird’s Health Care Group and leader of the firm’s FDA Compliance & Enforcement Team, has been recognized by The National Law Journal in its third annual list of professionals identified as agents of change in health care and life sciences law.

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