Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...

Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”) [2] for Hemady ®, a drug indicated in combination with other anti-myeloma products for the treatment of ...

The FDA says state-licensed compounding pharmacies must immediately stop making compound versions of GLP-1 drugs. Larger, national licensed facilities making compound versions of Zepbound have until ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.

Diagnos Inc. (“ DIAGNOS ” or the “ Corporation ”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues through the use of its FLAIRE platform based on ...

US health secretary Robert F Kennedy Jr has asked the FDA to close a 'loophole' to self-affirm ingredients as GRAS. What does ...

Health and Human Services Secretary Robert Kennedy has begun his campaign to improve Americans’ health by increasing the U.S. Food and Drug Administration’ ...

Kennedy said the move is intended to improve consumer safety by increasing transparency in what is in the food people consume, especially ultraprocessed foods.

For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant ...