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postmarketing studies
With new guidance, FDA moves toward uniform postmarketing reporting
With new guidance, FDA moves toward uniform postmarketing reporting
RAPS.org
FDA
postmarketing studies
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FDA seeks withdrawal of Makena, generics from market
FDA seeks withdrawal of Makena, generics from market
RAPS.org
Amag Pharmaceuticals
Makena
FDA
preterm birth
postmarketing studies
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FDA: Most postmarketing requirements, commitments progressing on schedule
FDA: Most postmarketing requirements, commitments progressing on schedule
RAPS.org
FDA
postmarketing studies
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Study: Just Half of Postmarketing Commitment Trials are Published
Study: Just Half of Postmarketing Commitment Trials are Published
RAPS.org
postmarketing studies
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FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
Endpoints
FDA
cancer
postmarketing studies
accelerated approvals
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Gottlieb calls out Perrigo for missed postmarket study deadline
Gottlieb calls out Perrigo for missed postmarket study deadline
Biopharma Dive
FDA
Scott Gottlieb
social media
twitter
postmarketing studies
Perrigo
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FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies
FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies
RAPS.org
FDA
postmarketing studies
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FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
Pharmaceutical Processing
FDA
postmarketing studies
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