Results 61 to 70 of about 5,527 (127)

Authorisation and Withdrawal of Pharmaceutical Innovations in the European Union and in the United States (1995-2003) [PDF]

This is a comparative study of the average and median approval times for pharmaceutical innovations (new molecular entities -NMES- and new biologics), authorised in the United States (US) and in the European Union (EU) under the centralised procedure ...
Cabiedes Miragaya, Laura
core  

Development of live biotherapeutic products: a position statement of Asia-Pacific Microbiota Consortium. [PDF]

Gut
Tseng CH, Wong S, Yu J, Lee YY, Terauchi J, Lai HC, Luo JC, Kao CY, Yu SL, Liou JM, Wu DC, Hou MC, Wu MS, Wu JJ, Sung JJY, El-Omar EM, Wu CY.   +16 more
europepmc   +1 more source

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis. [PDF]

Lupus Sci Med
Li H, Xie W, Wang C, Guo C.
europepmc   +1 more source

Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON [PDF]

, 2016

core   +1 more source

A multicenter, postmarketing surveillance of elobixibat in patients with chronic constipation in Japan: A final analysis report. [PDF]

SAGE Open Med
Nakajima A, Umeyama M, Higashikawa M, Shimada Y, Arai Y.   +4 more
europepmc   +1 more source

Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]

Clin Pharmacol Ther
Mita S, Ono S.
europepmc   +1 more source

Conditional early approval for new drug applications in Japan: Current and emerging issues. [PDF]

Clin Transl Sci, 2023
Tanaka M, Miyazawa H, Terashima R, Ikuma M.   +3 more
europepmc   +1 more source

Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions. [PDF]

Pharmacoepidemiol Drug Saf
Guiriansoro Z, Oussova T, Weissfeld J.
europepmc   +1 more source

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

JAMA Intern Med, 2023
Wang X, Ayakulangara Panickan V, Cai T, Xiong X, Cho K, Cai T, Bourgeois FT.   +6 more
europepmc   +1 more source

Sacrificial Lambs: Compensating First Subscribers to FDA-approved Medications for Postmarketing Injuries Resulting from Unlabeled Adverse Events [PDF]

, 2013
Miller, Rodney K.
core   +2 more sources