Day: September 27, 2018

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 since the Food and Drug Administration … Read more

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 is now being … Read more