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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.
SAM.gov has been providing an automatic 30-day extension for any existing SAM.gov entity needing to be renewed with a registration date between April 29, 2022 and April 28, 2023. [7] CAGE codes are vital for small business to receive grants and contracts.
FDA Amendments Act of 2007: Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017
In the United States, federal grants are economic aid issued by the United States government out of the general federal revenue. A federal grant is an award of financial assistance from a federal agency to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States.
Faster drug approval times and other PDUFA-related changes have led to pharmaceutical companies targeting more drugs for first launch in the United States thus increasing patient access to new medicines. Faster drug review from 1990 to 2001 were found to increase the probability of a drug being launched first in the United States by 14%.
The U.S. Food and Drug Administration in 2023 recommended against the use of some China-made syringes as it investigated reports of leaks, breakages and other quality problems with such products ...
It requires the Foundation to: (1) identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness of such products; (2) establish goals and priorities; (3) identify federal research and development programs and minimize duplication; (4) award grants to scientists and entities to efficiently and effectively ...
US FDA approves Amgen drug for small cell lung cancer May 17, 2024 at 10:56 AM (This May 16 story has been officially corrected to change the pricing estimate in paragraph 4)