FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 11/6/2020.
Medical Devices
Certificate for Devices Not Exported from U.S.
FDA implements a certification program for medical devices not exported from the U.S.
Human Drugs
Guide on Insanitary Conditions at Compounding Facilities
FDA releases a final guidance on Insanitary Conditions at Compounding Facilities.
Human Drugs
Sanhwa Biosciences Silmitasertib Study Proceeding
Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education, has received a study-may-proceed letter from FDA to begin a ...
Medical Devices
Covid-19 Helps Advance RWE at FDA: Attorneys
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...
Human Drugs
Sedor Pharma Sesquient OKd for Status Epilepticus
FDA approves a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adult and pediatric pati...
Human Drugs
FDA Extends Review of Lipocine Testosterone Product
FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult male...
Human Drugs
Nostrum Recalls Some Metformin for NDMA Contamination
FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.
Federal Register
Comments Sought on FDA Posting REMS Assessments
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...
