Regulatory Watch

Jan 02, 2018
Pharmaceutical Technology
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
Dec 02, 2017
Pharmaceutical Technology
New gene therapies and combination products require innovative regulatory approaches.
Nov 21, 2017
By Pharmaceutical Technology Editors
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
Nov 02, 2017
Pharmaceutical Technology
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Oct 05, 2017
By Pharmaceutical Technology Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Oct 02, 2017
Pharmaceutical Technology
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Sep 02, 2017
Pharmaceutical Technology
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Aug 02, 2017
Pharmaceutical Technology
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Jul 02, 2017
Pharmaceutical Technology
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
Jul 02, 2017
Pharmaceutical Technology
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
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