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The Food and Drug Administration (FDA) is seeking public comments on a proposed collection of information as part of its requirement for the Office of Management and Budget (OMB) review under the Paperwork Reduction Act of 1995. This initiative pertains to the application process for FDA approval to market new drugs, covering the submission of data and patent details as specified in FDA regulations. The FDA has developed specific forms to aid applicants and has made updates to the process to improve efficiency. Public comments on these proposals are welcomed by March 18, 2021.

Aphena Pharma Solutions MD, LLC has applied to the Drug Enforcement Administration (DEA) to be a registered importer of certain controlled substances. These substances will be used internally to manufacture an over-the-counter drug that is approved by the FDA. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections to this application by April 7, 2025. They can also request a hearing on the application within the same deadline.

The Food and Drug Administration (FDA) has issued a priority review voucher to the sponsor of the rare pediatric disease product, CRENESSITY (crinecerfont). This voucher is awarded under the Federal Food, Drug, and Cosmetic Act, which allows such recognition for approved products meeting specific criteria. CRENESSITY is manufactured by Neurocrine Biosciences, Inc., and was approved on December 13, 2024, for the treatment of classic congenital adrenal hyperplasia in adults and children aged four and older. This announcement fulfills FDA's requirement to publish notice of such awards.

Leading Pharma LLC has applied to register as an importer of controlled substances. This application is for research and development purposes, aiming toward creating a new pharmaceutical product that is pending approval by the Food and Drug Administration (FDA). Interested parties can submit comments or request a hearing regarding this application, with a deadline of January 17, 2025. The Drug Enforcement Administration (DEA) will approve the application only if it meets specific legal criteria.

The Food and Drug Administration (FDA) has announced that they approved the use of ALYFTREK, a drug made up of vanzacaftor, tezacaftor, and deutivacaftor, on December 20, 2024. This approval includes the use of a priority review voucher, which is a special designation given to sponsors of drugs for rare pediatric diseases. These vouchers are part of a program designed to encourage the development of treatments for rare conditions found in children. For more information, individuals can visit the FDA's official website linked in the document.

VHG Labs, doing business as LGC Standards, has applied to the Drug Enforcement Administration (DEA) to register as an importer of specific controlled substances for analytical testing purposes. The DEA has announced this in the Federal Register and is accepting comments or objections from registered bulk manufacturers and other interested parties until February 24, 2025. Requests for a hearing related to this application must also be sent to the DEA by this date. The authorization sought does not include the importation of finished dosage forms approved by the Food and Drug Administration for commercial sale.