Newsletter - September 27, 2018
FDA Is “Writing Off” PDUFA Meetings Via “Written Response Only” Loophole
Over the last few years, FDA is increasingly refusing to meet companies, either in-person or via phone, and instead providing written responses to the applicant’s questions, a process called “Written Response Only (WRO)”. The WRO process which was originally created to make it easier to answer routine questions in certain meeting requests... Read More
Monetary Fines for Failing to Post Results on Clinicaltrials.gov
There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years ...Read More
FDA Is “Writing Off” PDUFA Meetings Via “Written Response Only” Loophole
Over the last few years, FDA is increasingly refusing to meet companies, either in-person or via phone, and instead providing written responses to the applicant’s questions, a process called “Written Response Only (WRO)”. The WRO process which was originally created to make it easier to answer routine questions in certain meeting requests... Read More
Monetary Fines for Failing to Post Results on Clinicaltrials.gov
There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years ...Read More
