postmarketing studies

FDA finalizes guidances on device post-approval studies, postmarket surveillance
RAPS.org
Tue, 10/11/22 - 10:37 am
FDA
regulatory
devices
Medtech
post-approval studies
postmarketing studies
Roche pulls Tecentriq breast cancer nod after post-approval trial flop
Fierce Pharma
Sat, 08/28/21 - 09:04 pm
Roche
Tecentriq
breast cancer
triple negative breast cancer
postmarketing studies
With new guidance, FDA moves toward uniform postmarketing reporting
RAPS.org
Tue, 10/20/20 - 10:03 pm
FDA
postmarketing studies
FDA seeks withdrawal of Makena, generics from market
RAPS.org
Mon, 10/5/20 - 11:51 pm
Amag Pharmaceuticals
Makena
FDA
preterm birth
postmarketing studies
FDA: Most postmarketing requirements, commitments progressing on schedule
RAPS.org
Thu, 08/6/20 - 11:02 pm
FDA
postmarketing studies
Study: Just Half of Postmarketing Commitment Trials are Published
RAPS.org
Mon, 06/17/19 - 11:24 pm
postmarketing studies
FDA should reassess postmarket trials for cancer drugs approved via accelerated pathway, researchers say
Endpoints
Wed, 05/29/19 - 10:22 am
FDA
cancer
postmarketing studies
accelerated approvals
Gottlieb calls out Perrigo for missed postmarket study deadline
Biopharma Dive
Wed, 06/27/18 - 08:59 pm
FDA
Scott Gottlieb
social media
twitter
postmarketing studies
Perrigo
FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies
RAPS.org
Mon, 09/25/17 - 09:40 am
FDA
postmarketing studies
FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
Pharmaceutical Processing
Thu, 09/3/09 - 10:35 am
FDA
postmarketing studies