post-marketing studies

Organon publishes post-market study of JADA PPH control system
Organon publishes post-market study of JADA PPH control system
Clinical Trials Arena
Organon
post-marketing studies
JADA
postpartum hemorrhage
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Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA
Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA
Endpoints
Sanofi
Regeneron
Libtayo
cervical cancer
post-marketing studies
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FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)
FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)
FDA Law Blog
regulatory
FDA
post-marketing studies
PDUFA VII
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FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs
FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs
RAPS.org
FDA
post-marketing studies
breast cancer
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Older adults, Black patients underrepresented in post-marketing studies
Older adults, Black patients underrepresented in post-marketing studies
RAPS.org
cancer
post-marketing studies
FDA
elderly
racial discrimination
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Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites
Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites
RAPS.org
clinical trials
clinical trial diversity
RWE
post-marketing studies
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EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
Endpoints
EMA
Pfizer
Europe
Xeljanz
post-marketing studies
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FDA Updates on Essure Postmarketing Study
FDA Updates on Essure Postmarketing Study
RAPS.org
Bayer
Essure
FDA
contraceptives
post-marketing studies
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Pfizer drops higher dose treatment arm in Xeljanz post-marketing study due to safety issues
Pfizer drops higher dose treatment arm in Xeljanz post-marketing study due to safety issues
CP Wire
Pfizer
Xeljanz
post-marketing studies
FDA
rheumatoid arthritis
ulcerative colitis
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Pfizer drops higher dose treatment arm in Xeljanz post-marketing study due to safety issues
Pfizer
Xeljanz
post-marketing studies
FDA
rheumatoid arthritis
ulcerative colitis
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FDA approves new protocol for study on Bayer's birth control device
FDA approves new protocol for study on Bayer's birth control device
Reuters
Bayer
Essure
devices
post-marketing studies
birth control
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Postmarketing study delays increase, but Gottlieb hopeful on progress
Postmarketing study delays increase, but Gottlieb hopeful on progress
BioCentury
FDA
post-marketing studies
Scott Gottlieb
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