Bonnie Odom

Epstein Becker & Green

+ Follow Contact

Latest Posts › Food and Drug Administration (FDA)

Share:

Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more

11/21/2023 / Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Information Sharing , Life Sciences , Medical Devices , Pharmaceutical Industry

Congress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs

On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more

1/20/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs

Podcast: Is the Dietary Supplement Regulatory Framework Working? - Diagnosing Health Care [Video]

The COVID-19 pandemic spurred record growth in the dietary supplement industry in 2020. With this heightened consumer interest and many new entrants to the market, important questions have emerged about the adequacy of the...more

10/21/2021 / Dietary Supplements , Enforcement Actions , Food and Drug Administration (FDA) , Health and Safety , Regulatory Oversight

3 Results

View per page

Page: of 1