Summary

MHRA ‘GXP’ Data Integrity Guidance and Definitions

25 April 2018
Read More
Summary

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

26 March 2018
Read More
Summary

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

19 March 2018
Read More
Summary

FDA Unique Device Identification: Direct Marking of Devices

5 March 2018
Read More
Summary

FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

16 February 2018
Read More
Rx REPORT

CDER Issues Planned Guidance Agenda for CY2018

22 January 2018
Read More
Rx REPORT

U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics

5 January 2018
Read More
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FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers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FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA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