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May 20, 2022

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia

On May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). Efficacy was […]
May 20, 2022

Clinical Investigator Training Course (CITC) Update – 12/07/2021

On This Page Date: December 7 – 8, 2021 Day1: Tue, Dec 7 1:00 PM – 5:00 PM ET Day2: Wed, Dec 8 1:00 PM – […]
May 20, 2022

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Summary Company Announcement Date: May 29, 2018 FDA Publish Date: March 27, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Due to […]
May 19, 2022

Frequently requested or proactively posted drug-specific and other records

5/19/2022 Epidemiology Review: Consumer Opioid Disposal Literature Scan and Search Results (dated April 29, 2021) (PDF – 569KB) 7/31/2020 FDA Letter to USP:  Reporting Threshold in USP-NF […]
May 19, 2022

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Summary Company Announcement Date: July 07, 2020 FDA Publish Date: July 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter […]
May 19, 2022

FDA’s “All-in” Approach to Enterprise Transformation

Image By: Janet Woodcock, M.D., Principal Deputy Commissioner, and Meredith Chuk, M.D., Senior Medical Advisor, Director, Enterprise Transformation Operation  Janet Woodcock, M.D., Principal Deputy Commissioner The […]
May 19, 2022

Risk Management Plans to Mitigate the Potential for Drug Shortages

Submit Comments by 07/19/2022 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 19, 2022

Office of Prescription Drug Promotion (OPDP) Research

The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and healthcare […]
May 19, 2022

Drug Supply Chain Security Act (DSCSA) Implementation Plan

The following table highlights certain deliverables described in the law.  As FDA works with stakeholders to implement the provisions of the law, additional deliverables may be […]
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