Results 101 to 110 of about 775,940 (231)

Assessment of the impact of Japanese-specific long-term safety data on new drug approval. [PDF]

Clin Transl Sci, 2021
Uzu S, Sekine S, Asano J, Ikuma M.
europepmc   +1 more source

'Fast-track' drug approvals hit speed bumps in Japan [PDF]

, 2004
Douglas Sipp
openalex   +1 more source

U.S. Food and Drug Administration Approval of AmBisome (Liposomal Amphotericin B) for Treatment of Visceral Leishmaniasis

, 1999
Andrea Meyerhoff
openalex   +1 more source

Accelerated Approval Seen as Triumph and Roadblock for Cancer Drugs [PDF]

, 2004
Elizabeth J. Susman
openalex   +1 more source

Twelve years of European cancer drug approval-a systematic investigation of the 'magnitude of clinical benefit'. [PDF]

ESMO Open, 2021
Grössmann N, Wolf S, Rothschedl E, Wild C.   +3 more
europepmc   +1 more source

Anticancer Drug Development: Preclinical Screening, Clinical Trials and Approval [PDF]

, 2004
David L. Selwood
openalex   +1 more source

Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness. [PDF]

Front Med (Lausanne), 2021
McPhail M, Weiss E, Bubela T.
europepmc   +1 more source

Erratum: Anticancer drug development: preclinical screening, clinical trials and approval [PDF]

, 2004
B A Teicher, David L. Selwood, Paul A. Andrews   +2 more
openalex   +1 more source

Regulatory efforts to address the access gap for foreign new drugs in China: the priority review program and related policies

Global Health Research and Policy
Background China has implemented the priority review (PR) program and flexible registration requirements for new drugs with significant clinical value since 2016 to accelerate drug access.
Xingyue Zhu, Jinsui Zhang
doaj   +1 more source

Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval. [PDF]

J Natl Cancer Cent, 2021
Huang H, Miao H, Wang J, Wu D, Lei Q, Wang S, Fang H, Tang Y, Li N, Xu B, He J.   +10 more
europepmc   +1 more source