FDA MAP
  • Home
  • Training
    • WORKSHOPS
    • WEBINARS
    • CUSTOM TRAINING
  • SERVICES
    • REGULATORY SERVICES
    • FDA AUDITING
    • QUALITY ASSURANCE
    • CLINICAL TRIAL SERVICES
  • News Releases
  • About Us
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


Our Services

  • Workshops
  • Webinars
  • On-Demand Webinars
  • Custom training
  • Training Subscriptions
  • Corporate Registration
  • Certification Program
  • Smart Recruitment
  • Corporate Registration - Online Workshop​

Company

  • About Us​
  • Testimonials
  • Free Resources
  • Newsletter
  • Videos (Free Tutorials)

Support

  • Contact Us
  • Terms of Service
  • Privacy Policy
  • News Archive
Consultation Service
FDA Training Company
Copyright © 2022 FDAMap.com
Use of this Web site constitutes acceptance of the FDAMap Terms of Use and Privacy Policy.