USA - January 12 2021
On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection...
David Horowitz.
USA - December 14 2020
The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination...
David M. Fox, Randy Prebula.
USA - November 19 2020
The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a...
David Horowitz, Stuart M. Langbein, Philip Katz, Randy Prebula.
USA - November 12 2020
On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial...
Blake E. Wilson, Robert Church, Eman Al-Hassan.
USA - October 25 2020
Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing...
Meredith Manning, Susan S. Lee.