Rx ALERT

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

29 September 2017
Read More
Rx REPORT

African Medicines Agency endorsed by Ministers of Health

19 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
Summary

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

1 August 2017
Read More
Summary

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices

1 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