Standards & Regulations

Mar 20, 2018
By BioPharm International Editors
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
Mar 16, 2018
By BioPharm International Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 08, 2018
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
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.
Mar 01, 2018
BioPharm International
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
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The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.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 14, 2018
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
Feb 12, 2018
By BioPharm International Editors
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
native1_300x100
lorem ipsum