Rx REPORT

FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers

28 November 2017
Read More
Rx REPORT

FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

28 November 2017
Read More
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
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