💊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⚖️DEA Temporarily Schedules New Synthetic Opioids - Compliance Needed
The Drug Enforcement Administration issues this temporary order to schedule two benzimidazole-opioids in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing these substances in schedule I is necessary to avoid imminent hazard to public safety. This order imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle these substances.
Learn More💊FDA's Draft Guidance on Q1 Stability Testing for Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Q1 Stability Testing of Drug Substances and Drug Products." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines stability data expectations for drug substances and drug products to support drug product marketing, including marketing authorization applications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 This draft guidance is a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997,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 Notice on Patent Extension for VAFSEO Drug Regulations
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VAFSEO 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 Pediatric Advisory Committee Meeting Notice for Public Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More💊FDA Report on Drug Firms' Postmarketing Requirements and Commitments
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https://www.fda.gov/drugs/postmarketing- requirements-and-commitments-introduction/postmarketing-requirements- and-commitments-reports).
Learn More💊FDA Determines Regulatory Review Period for ADBRY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADBRY 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 biological product.
Learn More💊Bulk Manufacturer Registration Application by Pisgah Laboratories
Pisgah Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More🚫FDA Debars Alnashir Punjani for 5 Years
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Alnashir Alibhai Punjani for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Punjani was convicted of one felony count under Federal law for conspiracy to deliver and introduce unapproved drugs. The factual basis supporting Mr. Punjani's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Punjani was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 10, 2024 (30 days after receipt of the notice), Mr. Punjani had not responded. Mr. Punjani's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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