FDA Records Access Authority for Cosmetics: Draft Guidance Now Available
The U.S. Food and Drug Administration has announced the availability of a new draft guidance titled “FDA Records Access Authority for Cosmetics: Guidance for Industry.” The document addresses frequently asked questions about FDA’s authority to access records related...
Durbin Introduces Legislation To Improve Transparency and Safety of Dietary Supplements
U.S. Senate Democratic Whip Dick Durbin has reintroduced the Dietary Supplement Listing Act, legislation aimed at improving transparency and safety in the dietary supplement market.
Artificial Intelligence: Quality Friend or Foe
This Issue of the Month explores how artificial intelligence is being applied in regulated industries, examining potential benefits for quality and compliance programs while highlighting risks and considerations companies should evaluate before integrating AI into regulatory operations.
Drug and Device Corner 2025 December
Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the...