Results 321 to 330 of about 1,107,201 (376)

FDA Modernization Act 2.0 allows for alternatives to animal testing.

Artificial Organs, 2023
On December 29, 2022, President Biden signed into law the FDA Modernization Act 2.0. The bill essentially refutes the Federal Food, Drug, and Cosmetics Act of 1938, which mandated animal testing for every new drug development protocol. While for the past
Jason J. Han
semanticscholar   +1 more source

U.S. FDA Approved Drugs from 2015-June 2020: A Perspective.

Journal of Medicinal Chemistry, 2021
In the present work, we report compilation and analysis of 245 drugs, including small and macromolecules approved by the U.S. FDA from 2015 until June 2020. Nearly 29% of the drugs were approved for the treatment of various types of cancers.
Priyadeep Bhutani, G. Joshi, N. Raja, Namrata Bachhav, P. Rajanna, H. Bhutani, A. Paul, Raj Kumar   +7 more
semanticscholar   +1 more source

An Update on the Nitrogen Heterocycle Compositions and Properties of U.S. FDA-Approved Pharmaceuticals (2013-2023).

Journal of Medicinal Chemistry
This Perspective is a continuation of our analysis of U.S. FDA-approved small-molecule drugs (1938-2012) containing nitrogen heterocycles. In this study we report drug structure and property analyses of 321 unique new small-molecule drugs approved from ...
Christopher M Marshall, John G Federice, Chloe N Bell, Philip B Cox, Jon T Njardarson   +4 more
semanticscholar   +1 more source

A Decade of FDA-Approved Drugs (2010-2019): Trends and Future Directions.

Journal of Medicinal Chemistry, 2021
A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class ...
Dean G. Brown, Heike J Wobst
semanticscholar   +1 more source

FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

Journal of the American Medical Association (JAMA)
Importance Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks.
Haider J. Warraich, Troy Tazbaz, R. Califf   +2 more
semanticscholar   +1 more source

FDA update

Epilepsy Research, 2006
This report addresses: (1) a general update of FDA activity in areas relevant to AED development; (2) an update on issues relevant to the development of AEDs in the pediatric population; and (3) an update on the Agency's approach to the evaluation of AEDs as monotherapy.
openaire   +2 more sources

FDA-MIMO Transmitter and Receiver Optimization

IEEE Transactions on Signal Processing
This paper addresses the joint design of the transmit parameters (i.e., radar code/frequency increments) and the receive filter in a Frequency Diverse Array (FDA)-Multiple-Input Multiple-Output (MIMO) radar system.
Lan Lan, M. Rosamilia, A. Aubry, A. De Maio, Guisheng Liao   +4 more
semanticscholar   +1 more source

Today's FDA

New England Journal of Medicine, 2005
In 1992, the passage of the Food and Drug Administration (FDA) Prescription Drug User Fee Act and, in 1997, the FDA Modernization Act resulted in an 85 percent increase in the number of employees at the FDA and in more efficient processes for the approval of drugs. In this article, the author identifies the remaining challenges facing the FDA.
openaire   +2 more sources