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Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
Drug Manufacturer Indication Crizotinib: PF Prism: ALK-positive systemic anaplastic large cell lymphoma: Trastuzumab deruxtecan: Daiichi Sankyo: HER2-positive gastric or gastroesophageal junction adenocarcinoma, previously treated with trastuzumab
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
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An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
In the United States, the FDA approves drugs.Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2]
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.
Pfizer has been actively dealmaking and receiving FDA approvals for new products and new indications in the past couple of years, but that has all been overshadowed by its runaway success with ...