post-marketing studies

Organon publishes post-market study of JADA PPH control system
Clinical Trials Arena
Fri, 09/15/23 - 11:45 am
Organon
post-marketing studies
JADA
postpartum hemorrhage
Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA
Endpoints
Sun, 01/30/22 - 11:42 am
Sanofi
Regeneron
Libtayo
cervical cancer
post-marketing studies
FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)
FDA Law Blog
Fri, 10/8/21 - 10:38 am
regulatory
FDA
post-marketing studies
PDUFA VII
FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs
RAPS.org
Mon, 06/21/21 - 10:13 pm
FDA
post-marketing studies
breast cancer
Older adults, Black patients underrepresented in post-marketing studies
RAPS.org
Wed, 04/28/21 - 09:51 pm
cancer
post-marketing studies
FDA
elderly
racial discrimination
Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites
RAPS.org
Mon, 03/29/21 - 11:03 pm
clinical trials
clinical trial diversity
RWE
post-marketing studies
EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
Endpoints
Sat, 05/18/19 - 08:47 pm
EMA
Pfizer
Europe
Xeljanz
post-marketing studies
FDA Updates on Essure Postmarketing Study
RAPS.org
Thu, 05/16/19 - 10:01 am
Bayer
Essure
FDA
contraceptives
post-marketing studies
Pfizer drops higher dose treatment arm in Xeljanz post-marketing study due to safety issues
CP Wire
Wed, 02/20/19 - 11:52 am
Pfizer
Xeljanz
post-marketing studies
FDA
rheumatoid arthritis
ulcerative colitis
Pfizer drops higher dose treatment arm in Xeljanz post-marketing study due to safety issues
Wed, 02/20/19 - 11:51 am
Pfizer
Xeljanz
post-marketing studies
FDA
rheumatoid arthritis
ulcerative colitis
FDA approves new protocol for study on Bayer's birth control device
Reuters
Fri, 12/21/18 - 11:04 pm
Bayer
Essure
devices
post-marketing studies
birth control
Postmarketing study delays increase, but Gottlieb hopeful on progress
BioCentury
Fri, 11/16/18 - 08:00 pm
FDA
post-marketing studies
Scott Gottlieb