Rx REPORT
U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles
4 January 2018
Rx REPORT
U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers
4 January 2018
Rx REPORT
U.S. FDA Announces Pilot Program – Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot
4 January 2018
Rx REPORT
U.S. FDA Issues Revised MAPP on Naming of Drug Products Containing Salt Drug Substances
27 December 2017
Rx REPORT
FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers
28 November 2017
Rx REPORT
FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA
28 November 2017
Summary
Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff
14 November 2017
Summary
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
11 September 2017
Rx REPORT
FDA Announces Pilot Project Program Under the Supply Chain Security Act
3 August 2017
