Standards/Regulations

Jun 01, 2017
BioPharm International
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 01, 2017
BioPharm International
Approval of breakthrough therapies requires expedited quality assessment.
May 30, 2017
By BioPharm International Editors
The company was cited for cGMP violations at its Irvine, California facility.
May 24, 2017
By BioPharm International Editors
The agency met with the representatives of the East African Community to discuss the creation of a networking agency.
May 23, 2017
By BioPharm International Editors
FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.
May 23, 2017
By BioPharm International Editors
CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
May 22, 2017
By BioPharm International Editors
The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.
May 15, 2017
BioPharm International
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
May 15, 2017
BioPharm International
BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.
May 09, 2017
By BioPharm International Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
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