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August 18, 2020

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes FDA’s compliance policy related to the retention of reserve samples of the […]
August 17, 2020

CDER Leadership Bios

Eric Stone, M.B.A.Director, Office of Management Eric Stone is Director of CDER’s Office of Management. He also serves as the CDER Executive Officer and CDER’s Associate […]
August 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020

For Immediate Release: August 17, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
August 17, 2020

Drug Trials Snapshots: BLENREP

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 17, 2020

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

For Immediate Release: August 17, 2020 The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in […]
August 17, 2020

Drug Trials Snapshots: LAMPIT

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 17, 2020

SilveryGuy – 609843 – 08/14/2020

Product: Drugs Date:               August 14, 2020 CC:                  [email protected] –   Amazon Associates Program RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 […]
August 17, 2020

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment

Submit Comments by 10/13/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
August 16, 2020

SG24 LLC Issues Voluntary Nationwide Recall of SkinGuard24 Hand Sanitizer Labeled to Contain Methanol

Summary Company Announcement Date: August 14, 2020 FDA Publish Date: August 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Methanol Company Name: […]
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