Results 121 to 130 of about 25,533 (219)

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

Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process [PDF]

, 2011
Kassel, Mark A.
core   +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

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

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance

Therapeutic Innovation and Regulatory Science, 2018
R. Izem, Matilde Sanchez-Kam, Haijun Ma, Richard C. Zink, Yueqin Zhao   +4 more
semanticscholar   +1 more source

Safety and effectiveness of intravenous abatacept for polyarticular-course juvenile idiopathic arthritis: An all-case postmarketing surveillance study. [PDF]

Pediatr Rheumatol Online J
Nozawa T, Iwata N, Igarashi T, Kobayashi I, Ota S, Yamada T, Bando E, Habiro K, Takei S.   +8 more
europepmc   +1 more source

Application of a Language Model Tool for COVID-19 Vaccine Adverse Event Monitoring Using Web and Social Media Content: Algorithm Development and Validation Study. [PDF]

JMIR Infodemiology
Daluwatte C, Khromava A, Chen Y, Serradell L, Chabanon AL, Chan-Ou-Teung A, Molony C, Juhaeri J.   +7 more
europepmc   +1 more source

Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment. [PDF]

Ther Innov Regul Sci
Alexe A, Garg A, Kovacs B, Abramova N, Apara O, Eisele O, Fernandes MFS, Balramsingh-Harry L, Wurst K, Lewis D.   +9 more
europepmc   +1 more source

Real-World Safety of Esketamine Nasal Spray: A Comprehensive Analysis of Esketamine and Respiratory Depression. [PDF]

Int J Neuropsychopharmacol
Chepke C, Shelton R, Sanacora G, Doherty T, Tsytsik P, Parker N.   +5 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