March 7, 2022

Immunogenicity Information in Labeling – 04/05/2022

On This Page Date: April 5, 2022 Time: 11:00 AM – 12:30 PM ET Visit CDER Small Business and Industry Assistance Page This webinar has been […]
March 4, 2022

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

On March 4, 2022, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung […]
March 4, 2022

Public Notification: Wonderful Honey contains hidden drug ingredient

[3-4-2022] The Food and Drug Administration is advising consumers not to purchase or use Wonderful Honey, a product promoted for sexual enhancement on various websites and possibly […]
March 4, 2022

CDER Continues to Make Rare Diseases a Priority with Drug Approvals and Programming to Speed Therapeutic Development

Image By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research Patrizia Cavazzoni, M.D. A rare disease is any disease that affects less than 200,000 […]
March 3, 2022

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume

Summary Company Announcement Date: March 02, 2022 FDA Publish Date: March 03, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Fluid leakage and low […]
March 3, 2022

JBS Souderton, Inc. dba MOPAC – 574386 – 11/18/2019

Delivery Method: VIA UPS and Electronic Mail Product: Animal & VeterinaryDrugs Recipient: Recipient Name Todd Scherbing Recipient Title General Manager JBS Souderton, Inc. dba MOPAC 741 […]
March 2, 2022

Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA – 02/24/2022

On This Page Date: February 24, 2022 Time: 1:00 PM – 3:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR In […]
March 1, 2022

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

On February 28, 2022, the Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory […]
March 1, 2022

Pediatric Tracking Requirements Under FDAAA

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
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