Summary

Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

14 November 2017
Read More
Rx ALERT

Request for Information – Disaster Impact Assessment in Puerto Rico and Other Locations

29 September 2017
Read More
Summary

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.

11 September 2017
Read More
Rx REPORT

FDA Announces Pilot Project Program Under the Supply Chain Security Act

3 August 2017
Read More

FDA – Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA)

3 August 2017
Read More
Rx REPORT

FDA Announces Exemptions from Premarket Notification for Class II Devices

12 July 2017
Read More
Rx REPORT

New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017

10 May 2017
Read More
Summary

FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

11 April 2017
Read More
Summary

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

6 April 2017
Read More
Rx ALERT

Second Chinese company found shipping APIs from a banned manufacturer

17 March 2017
Read More