Regulatory Beat

Jul 02, 2018
BioPharm International
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Jul 01, 2018
BioPharm International
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Jun 01, 2018
BioPharm International
FDA and Congress seek to limit the production and distribution of pain medicines.
May 01, 2018
BioPharm International
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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.
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