RAPS

FDA warns Japanese firm for particle contamination, takes mask-maker to task — again

The US Food and Drug Administration (FDA) admonished Japanese pharmaceutical manufacturer Toyoba Co. in a recent warning letter for taking a lax approach to fixing microbiological contamination issues ...
Nasdaq

FDA clears first particulate placental extracellular matrix medical device for wound management

MEMPHIS, Tenn., Feb. 23, 2023 /PRNewswire/ -- Convatec today announced it has received clearance from the U.S. Food and Drug Administration for its InnovaMatrix® PD particulate placental extracellular ...
Yahoo Finance

StimLabs® Announces FDA 510(k) Clearance for DermaForm™, a Collagen Scaffold Particulate Wound Care Device

ROSWELL, Ga., Feb. 12, 2026 /PRNewswire/ -- StimLabs, a leading regenerative medicine company, announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Geistlich's ...
RAPS

FDA warns Emergent BioSolutions over GMP violations at Camden facility

The US Food and Drug Administration (FDA) issued a warning letter to Emergent BioSolutions subsidiary Cangene BioPharma outlining violations of current good manufacturing practice (CGMP) regulations ...
MD&M East

New FDA Crackdowns: How Device Makers Can Avoid Costly Mistakes

At the end of 2025, FDA will be revising its guidance on ISO 10993-1, leaving medical device manufacturers to spend the remaining months of the year preparing for regulatory changes. FDA is also ...
Healthcare Finance News

FDA criticizes drugmaker for 'significant violations'

The Food and Drug Administration has issued a stern warning to Amneal Pharmaceuticals for what it called “significant violations” of manufacturing standards, citing instances in which the drugmaker ...