Regulatory/GMP Compliance

Mar 16, 2018
By BioPharm International Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
Mar 15, 2018
BioPharm International
Process validation is an extension of biologics development processes.
Mar 15, 2018
BioPharm International
Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
Mar 15, 2018
BioPharm International
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 01, 2018
BioPharm International
FDA enforcement efforts and drug approvals trend upward.
Mar 01, 2018
BioPharm International
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
Feb 21, 2018
By BioPharm International Editors
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
Feb 15, 2018
By BioPharm International Editors
FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.
Feb 15, 2018
By BioPharm International Editors
The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.
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