💊FDA Announces Regulatory Review Period and Patent Extension for AGAMREE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGAMREE 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 drug product.
Learn More🌿FDA Seeks Nominations for Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees, and therefore encourages nominations of appropriately qualified candidates. Specifically, TPSAC is seeking to fill 5 vacancies with physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty. Included in the 5 vacancies is 1 vacancy for a representative of the general public, and 1 vacancy for an employee of a state or local government or of the Federal Government.
Learn More💊FDA Notice on Regulatory Review Period for FILSPARI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSPARI 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 Patent Extension Determination for EDWARDS SAPIEN 3 ULTRA RESILIA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 ULTRA RESILIA premarket approval application (PMA) 140031 supplement (S-141) 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 medical device.
Learn More📋FDA Adverse Event Reporting Program
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊FDA's Draft Guidance on Q1 Stability Testing for Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Q1 Stability Testing of Drug Substances and Drug Products." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines stability data expectations for drug substances and drug products to support drug product marketing, including marketing authorization applications and, where applicable, drug master files. This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July 1996, respectively. The revision also provides stability related guidance for product categories such as advanced therapy medicinal products, vaccines, and other complex biological products including combination products that were not previously covered under the existing stability guidances. The draft guidance is intended to provide an internationally harmonized approach to conducting and presenting data on stability testing for drug substances and drug products, as well as providing alternative, scientifically justified approaches that may be encountered due to scientific considerations and characteristics of the data being evaluated.
Learn More💊FDA Determines Regulatory Review Period for ZILBRYSQ Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZILBRYSQ 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 drug product.
Learn More💊FDA Patent Extension Notice for COLUMVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for COLUMVI 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💊FDA Notice on BREYANZI Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BREYANZI 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💊FDA Regulatory Review Period Determination for TRUQAP
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRUQAP 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 drug product.
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