💊FDA Announces Regulatory Review Period for MIPLYFFA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MIPLYFFA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Learn More💊FDA Decision Opens Path for SEMPREX-D Generic Drug Approvals
The Food and Drug Administration (FDA or Agency) has determined that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met.
Learn More💉FDA Announces Draft Guidance for Regenerative Medicine Therapies
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry." The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. This draft guidance, when finalized, will supersede the final guidance of the same title dated February 2019.
Learn More📊FDA Notice on Good Manufacturing Practices for PET Drugs
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collection of information under FDA's current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drug products. PET is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product.
Learn More🚗U.S. Notice on Tariff Modifications Under New EU Framework Agreement
On August 21, 2025, the United States and the European Union announced agreement on a Framework on an Agreement on Reciprocal, Fair, and Balanced Trade (Framework Agreement). On September 5, 2025, President Trump issued Executive Order 14346, Modifying the Scope of Reciprocal Tariffs and Establishing Procedures for Implementing Trade and Security Agreements, finding that it is necessary and appropriate to implement the tariff modifications described in that Framework Agreement. Executive Order 14346 also directed and authorized the Secretary of Commerce and the United States Trade Representative to take the necessary and appropriate steps to implement any current or forthcoming trade and security framework agreements between a foreign trading partner and the United States. This notice amends the Harmonized Tariff Schedule of the United States to implement the elements of the Framework Agreement that adjust tariffs on certain articles that are products of the European Union, including automobiles and automobile parts subject to tariffs under Proclamation 10908, Adjusting Imports of Automobiles and Automobile Parts Into the United States, as amended, and unavailable natural resources (including cork), all aircraft and aircraft parts, and generic pharmaceuticals and their ingredients and chemical precursors.
Learn More❌FDA Withdraws Approval of 72 Drug Applications - Business Impact
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 72 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.
Learn More📋Regulatory Changes from HHS
The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
Learn More💊DEA Adjusts Production Quota for Lisdexamfetamine and d-Amphetamine
The Drug Enforcement Administration (DEA) is adjusting the 2025 aggregate production quota for the schedule II controlled substances lisdexamfetamine and d-amphetamine (for conversion). In making this determination, DEA has considered the factors set forth in 21 CFR 1303.13(b) in accordance with 21 U.S.C. 826(a) and is expediting publication of this determination to comply with the timeframes specified in 21 U.S.C. 826(h)(1).
Learn More💊Proposed FTZ Production Activity for Grand River Aseptic Manufacturing
The Department of Commerce's Foreign-Trade Zones Board has received a notification regarding production activities for Grand River Aseptic Manufacturing in Michigan. The notification outlines the specific pharmaceutical products and foreign-status materials proposed for production under FTZ procedures, which could provide duty-free benefits. Public comments are invited before the closing date of October 27, 2025.
Learn More💊FDA Issues Draft Guidance for Developing Drugs for Erosive Esophagitis
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
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