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Certificate for Devices Not Exported from U.S.

[ Price : $8.95]

FDA implements a certification program for medical devices not exported from the U.S.

Guide on Insanitary Conditions at Compounding Facilities

[ Price : $8.95]

FDA releases a final guidance on Insanitary Conditions at Compounding Facilities.

Sanhwa Biosciences Silmitasertib Study Proceeding

[ Price : $8.95]

Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education, has received a study-may-proceed letter ...

Covid-19 Helps Advance RWE at FDA: Attorneys

[ Price : $8.95]

Attorneys from Hogan Lovells opine that the Covid-19 emergency has had the unintended consequence of cementing the use of real-wor...

Sedor Pharma Sesquient OKd for Status Epilepticus

[ Price : $8.95]

FDA approves a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adul...

FDA Extends Review of Lipocine Testosterone Product

[ Price : $8.95]

FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement t...

Nostrum Recalls Some Metformin for NDMA Contamination

[ Price : $8.95]

FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.

Comments Sought on FDA Posting REMS Assessments

[ Price : $8.95]

Federal Register notice: FDA establishes a docket to solicit public comment on a proposal to publish a summary of FDAs review of R...

FDA Accepts BioMarin Vosoritide NDA

[ Price : $8.95]

FDA sets 8/20/21 as the PDUFA action date for BioMarins vosoritide NDA to treat children with achondroplasia.

Bluebird Bio Readying BLAs

[ Price : $8.95]

Bluebird Bio reaches agreement with FDA on issues related to its submission of a BLA for LentiGlobin to treat sickle cell disease....