💊FDA Revokes Emergency Use Authorizations for COVID-19 Drugs
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Learn More⚖️Extension of Temporary Scheduling for Designer Benzodiazepines
The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of five designer benzodiazepines--clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam. In an order dated July 26, 2023, DEA temporarily placed these five substances in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of five designer benzodiazepines for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these five specified controlled substances.
Learn More👩⚕️Draft Guidance on Pregnant and Breastfeeding Women in Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.
Learn More💊Proposed Information Collection Comment Request by the DoD
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💊Cerilliant Corporation's Bulk Manufacturer Application Overview
Cerilliant Corporation 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 Notice on Patent Extension for KISUNLA Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISUNLA 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💊FDA Announces Regulatory Review Period for LAZCLUZE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAZCLUZE 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 Announces Regulatory Review Period for IMDELLTRA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMDELLTRA 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 Regulatory Review Period for ABRYSVO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABRYSVO 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💊Final Determination on Pirfenidone Tablets' Country of Origin
This document provides notice that U.S. Customs and Border Protection (CBP) has issued a final determination concerning the country of origin of pirfenidone tablets. Based upon the facts presented, CBP has concluded that the pirfenidone tablets would be the product of a foreign country or instrumentality designated pursuant to 19 U.S.C. 2511(b).
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