Medical Device Legal News with Sam Bernstein: Episode 11
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more