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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [ 1][ 2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug ...
On October 18, 1985, the DEA issued a Notice of Proposed Rulemaking to transfer "Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules" — a pill form of Δ 9-tetrahydrocannabinol, the main psychoactive component of cannabis, sold under the brand name Marinol — from Schedule I to Schedule II (DEA 50 FR 42186-87).
The company's lead product, Gattex ® 0.05 mg/kg/d (Teduglutide [rDNA origin]) for Injection is FDA-approved for the treatment of adult patients with short bowel syndrome (SBS) who are dependent ...
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.
AMAG Pharmaceuticals Announces FDA Submission of a Supplemental New Drug Application for Feraheme Label Expansion to Include All Iron Deficiency Anemia Patients Who Cannot Take Oral Iron LEXINGTON ...
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.