Notice
28 Apr 2025
business compliance, dea, controlled substances, pharmaceutical regulation, drug manufacturing
💊DEA Notice on Controlled Substances Application Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on March 26, 2025, concerning a notice of application for bulk manufacturer of Controlled Substances. As that document indicated the registrant's incorrect plans for the listed controlled substances.
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Regulatory Compliance, Pharmaceutical Industry
15 Jan 2025
healthcare, fda, pharmaceutical regulation, drug approvals, teva pharmaceuticals
🚫FDA Withdraws Approval of 23 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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