Results 321 to 330 of about 5,566,486 (385)

New Drugs Approved in 2020

The American Journal of Medicine, 2021
In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.
Alex M Ebied, Hesham Elmariah, Rhonda M Cooper-DeHoff   +2 more
openaire   +3 more sources

Flexible Drug Approval Policies

Manufacturing & Service Operations Management, 2018
Problem definition: To approve a novel drug therapy, the U.S. Food and Drug Administration (FDA) requires clinical trial evidence demonstrating efficacy with 2.5% statistical significance, although the agency often uses regulatory discretion when ...
Fernanda Bravo, Taylor C. Corcoran, Elisa F. Long   +2 more
semanticscholar   +1 more source

Drug Approval and Surveillance

International Journal of Gynecology & Obstetrics, 1980
ABSTRACTThe author proposes that current regulations governing the licensing of drugs, particularly in the United States, need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use.
openaire   +3 more sources

2017 FDA drug approvals

Nature Reviews Drug Discovery, 2018
This corrects the article DOI: 10.1038/nrd.2018.4.
openaire   +4 more sources

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review

JAMA Oncology, 2018
Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver, L. Howie, Lorraine C Pelosof, Tamy Kim, Jinzhong Liu, Kirsten B. Goldberg, R. Sridhara, G. Blumenthal, A. Farrell, P. Keegan, R. Pazdur, P. Kluetz   +11 more
semanticscholar   +1 more source

Drugs approved for small ruminants

Journal of the American Veterinary Medical Association, 2004
JAVMA, Vol 224, No. 4, February 15, 2004 F the purpose of this FARAD Digest, small ruminants are considered to include sheep, goats, deer, and camelids. In the United States, the small ruminant population is low, and they are all considered minor species under the Food, Drug, and Cosmetics Act (Table 1).
Jim E. Riviere, Arthur L. Craigmill, Ronald E. Baynes, Alistair I. Webb, Scott R. R. Haskell   +4 more
openaire   +3 more sources

Characteristics of expedited programmes for cancer drug approval in China

Nature reviews. Drug discovery, 2021
Guanqiao Li, Yang Liu, Cuicui Xie, Qing Zhou, Xiaoyuan Chen   +4 more
semanticscholar   +1 more source

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

Journal of Clinical Oncology, 2018
Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non-breakthrough-designated cancer drugs ...
T. Hwang, J. Franklin, Christopher T Chen, J. Lauffenburger, B. Gyawali, A. Kesselheim, Jonathan J. Darrow   +6 more
semanticscholar   +1 more source

Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment.

American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 2019
Historically, patient experience, including symptomatic toxicities, physical function, and disease-related symptoms during treatment or their perspectives on clinical trials, has played a secondary role in cancer drug development. Regulatory criteria for
B. Gyawali, T. Hwang, K. N. Vokinger, C. Booth, E. Amir, A. Tibau   +5 more
semanticscholar   +1 more source

Approval of New Drugs

Science, 1973
Sam Peltzman, Harry Wiener
  +6 more sources