Results 231 to 240 of about 25,779 (305)

A survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activities [PDF]

, 2016
Amita Joshi, Bert L. Lum, Chi-Chung Li, Dan Lu, Luna Musib, Mark Stroh, Priya Agarwal, Richard A. Graham, Tong Lu   +8 more
core   +1 more source

Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.

JAMA Netw Open
Mooghali M, Wallach JD, Ross JS, Ramachandran R.   +3 more
europepmc   +1 more source

Has risk management plan system influenced the speed of package insert revisions in Japan? [PDF]

Front Med (Lausanne)
Kameyama N, Hosaka A, Maeda H.
europepmc   +1 more source

Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

, 2016
Atsushi Nishikawa, Fumito Yoshiki, Masanori Taketsuna, Kenta Kajimoto, Hiroyuki Enomoto   +4 more
openalex   +2 more sources

Post-marketing analysis of Motor Threshold variability.

Brain Stimulation, 2021
Roman Gersner, Zach Leber, Aron Tendler, MD.   +2 more
doaj  

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

Treatment of Opioid-Induced Constipation: Inducing Laxation and Understanding the Risk of Gastrointestinal Perforation. [PDF]

J Clin Gastroenterol
Mehta N, Laitman AP, Brookfield RB, Harris LA.   +3 more
europepmc   +1 more source

A Sponsor's Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan. [PDF]

Pharmaceut Med
Wolter KD, Kamatani A, Suzuki Y, Imaeda T, Dagher R, Safferman A, Junor R.   +6 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

Testing of New Drugs Approved From 2015 Through 2021 Under the US Pediatric Research Equity Act.

JAMA
Liu ITT, Hwang TJ, Kesselheim AS.
europepmc   +1 more source