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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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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