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May 24, 2021

Division of Applied Regulatory Science | Publications

On this page Annual Reports 2018 Annual Report 2019 Annual Report 2020 Annual Report 2019 Regulatory Science Bai JPF, Earp JC, Pillai VC. Translational Quantitative Systems […]
May 24, 2021

Bispecific Antibody Development Programs Guidance for Industry

Docket Number: FDA-2019-D-0621 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to assist […]
May 21, 2021

Coronavirus (COVID-19) Update: May 21, 2021

For Immediate Release: May 21, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The […]
May 21, 2021

FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

On May 21, 2021, the Food and Drug Administration granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor […]
May 21, 2021

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

[embedded content] Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun […]
May 21, 2021

Guidance Recap Podcast: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics

Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
May 20, 2021

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Summary Company Announcement Date: January 08, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company […]
May 20, 2021

ICH Q12: Implementation Considerations for FDA-Regulated Products

Submit Comments by 07/19/2021 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 […]
May 20, 2021

FDA approves nivolumab for resected esophageal or GEJ cancer

On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer […]
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