FDA WRs

List

Regular expressions can be used, e.g. "pulm.*hypert". Click button 'View' for original U.S. FDA document.

Search WRs of interest

Timelines

The following events are shown with dates (only last event shown if dates are the same). S is issuing the original written request. Numbers indicate the planned completion of the original (0) or amended (1 or higher) written request. D is the determination. The blue vertical line indicates today.

Overall development timelines (please wait for plot to be generated)

Amendments

The histogram shows how many Written Requests were amended how many times. Only Written Requests with a Determination are shown, that is, those which are completed. Notes: Written Requests are issued selectively and based on certain data, thus cannot as such be compared with EMA PIPs. PREA required pediatric studies are not shown.

Histogram

Changes

Data in webapp

  • incomplete details extracted

Webapp

  • 2018-06-27 initial release
  • 2019-06-06 editorial update
  • 2019-09-22 update to website changes

Plans

  • include WR issued (not yet completed)
  • include PREA pediatric studies / developments

About

Contents

This webapp shows information that was automatically extracted from documents made publicly available by the U.S. FDA on their website: List of Determinations Including Written Request and Written Requests Issued.

Credits and disclaimer

The U.S. FDA is acknowledged as a source of information used in this webapp and should always be acknowledged by users. Consult the U.S. FDA's Website Policies here.

The correctness of information shown in this webapp is not verified and the information is not guaranteed to be correct. Extraction of information from PDF files is error-prone, and the information should be used cautiously. Users have the responsibility to verify the information they use.

Author and citation