Results 81 to 90 of about 1,046,073 (109)

The US Food and Drug Administration Cardiorenal Advisory Panel and the Drug Approval Process

Circulation, 2005
Dan Roden, Robert Temple
exaly  

Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC)

Critical Reviews in Oncology/Hematology, 2002
Yasuhiro Fujiwara
exaly  

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements

Clinical Trials, 2018
Joshua D Wallach, Huseyin Naci, Joseph S. Ross   +2 more
exaly  

Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer

European Journal of Clinical Pharmacology, 2019
Kenji Yamashita
exaly  

Real-world evidence and regulatory drug approval

Nature Reviews Clinical Oncology, 2020
Bishal Gyawali, Christopher M Booth, Michael J Raphael   +2 more
exaly  

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

JAMA - Journal of the American Medical Association, 2017
Huseyin Naci, Katelyn Rene Smalley
exaly  

DRUG APPROVAL

Chemical & Engineering News Archive, 2003
openaire   +1 more source

Canadian, European and United States new drug approval times now relatively similar

Regulatory Toxicology and Pharmacology, 2018
Nigel Rawson
exaly  

Drug Approvals

The Nurse Practitioner, 2008
openaire   +1 more source

New Flu Drug Approved

JAMA, 2018
openaire   +2 more sources