FDA implements a certification program for medical devices not exported from the U.S.
FDA releases a final guidance on Insanitary Conditions at Compounding Facilities.
Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education, has received a study-may-proceed letter from FDA to begin a ...
Attorneys from Hogan Lovells opine that the Covid-19 emergency has had the unintended consequence of cementing the use of real-world evidence and real...
FDA approves a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adult and pediatric pati...
FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult male...
FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.
Federal Register notice: FDA establishes a docket to solicit public comment on a proposal to publish a summary of FDAs review of Risk Evaluation and M...