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The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints . [ 1 ]
Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
This marked the start of the FDA approval process in its modern form. These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. [ 103 ] One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration ...
The Food and Drug Administration (FDA) has begun accelerating the process to fully approve the Pfizer-BioNTech COVID-19 vaccine, facing pressure to add resources from those who believe the lack of ...
Pfizer has said it plans to submit a request for FDA emergency approval in the coming days. Now, Moderna and Pfizer's vaccine candidates are at the head of the race, each reportedly working in ...
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
The U.S. Food and Drug Administration is holding a two-day public hearing to start the process of creating an abbreviated approval procedure for so-called biosimilar and interchangeable biological ...
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
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