Regulatory Beat

Apr 01, 2018
BioPharm International
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
Mar 01, 2018
BioPharm International
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Feb 01, 2018
BioPharm International
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Jan 01, 2018
BioPharm International
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
Dec 01, 2017
BioPharm International
New gene therapies and combination products require innovative regulatory approaches.
Nov 21, 2017
By BioPharm International 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 01, 2017
BioPharm International
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Nov 01, 2017
BioPharm International
Reliable, high-quality products require innovative analytics and production.
Oct 01, 2017
BioPharm International
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
Sep 01, 2017
BioPharm International
FDA works with industry on strategies for assuring high-quality regenerative medicines.
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