Upcoming Hearings/Markups - December 8 - House Agriculture Committee, Nutrition, Oversight, and Department Operations Subcommittee Hearing: “Review of USDA.
Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include.
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy.