Standards & Regulations

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The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.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.
Feb 08, 2018
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
Feb 07, 2018
By BioPharm International Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 07, 2018
By BioPharm International Editors
The agency met to discuss its new temporary and permanent premises in Amsterdam.
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