🧪FDA Determines Patent Extension for ZUNVEYL Drug Product
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZUNVEYL 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 Regulatory Review Period Determination for SOFDRA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOFDRA 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 claim that human drug product.
Learn More💊FDA Announces Regulatory Review Determination for OHTUVAYRE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OHTUVAYRE 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 patents which claim that human drug product.
Learn More💊FDA Announces Public Meeting on Drug User Fee Act and Hiring Assessment
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The topic to be discussed is a hiring and retention assessment which was performed by an independent contractor.
Learn More💊Vici Health Sciences' Import Application for Controlled Substances
Vici Health Sciences, LLC. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Executive Order on Pharmaceutical Supply Chain Resilience
Executive Order 14336 aims to strengthen the resilience of the American pharmaceutical supply chain by ensuring a stockpile of active pharmaceutical ingredients (APIs). It mandates the development of a critical drugs list and prioritizes domestic production, highlighting the government's efforts to enhance national security concerning essential medicines and medical countermeasures.
Learn More🧪FDA Announces Public Meeting on Biosimilar User Fee Act III
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting" and the availability of the report entitled "BsUFA III Regulatory Science Pilot Program Interim Report." The purpose of the public meeting is to review the progress of the BsUFA III Regulatory Science Program aims, or demonstration projects, and to solicit input on future research priorities. Under the BsUFA reauthorization commitment letter for fiscal years (FYs) 2023 through 2027 (BsUFA III), FDA committed to piloting a regulatory science program to facilitate biosimilar and interchangeable product development that focuses on: (1) advancing the development of interchangeable products; and (2) improving the efficiency of biosimilar product development. The purpose of the interim progress report is to provide a summary of activities that established the pilot program, an overview of research progress, and a brief discussion of future directions.
Learn More💊Notice of Controlled Substances Application by Galephar Pharmaceutical
Galephar Pharmaceutical Research Inc has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Proposed Information Collection for TRICARE Pharmaceutical Refunds
In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Learn More💊FDA Guidance on Formal Meetings for Biosimilar Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on August 11, 2023.
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