💊FDA Patent Extension Review for TECELRA and Business Implications
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECELRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊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.
Learn More🚫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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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