Regulatory Watch

Jun 02, 2018
Pharmaceutical Technology
FDA and Congress seek to limit the production and distribution of pain medicines.
Jun 01, 2018
Pharmaceutical Technology
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
May 02, 2018
Pharmaceutical Technology
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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 02, 2017
Pharmaceutical Technology
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Oct 02, 2017
Pharmaceutical Technology
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
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