Regulatory Watch

Apr 02, 2018
Pharmaceutical Technology
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Mar 02, 2018
Pharmaceutical Technology
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Feb 02, 2018
Pharmaceutical Technology
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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.
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