Standards & Regulations

Jul 25, 2017
By BioPharm International Editors
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
Jul 21, 2017
By BioPharm International Editors
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
Jul 21, 2017
By BioPharm International Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Jul 18, 2017
By BioPharm International Editors
The agency cited the Italian company for aseptic processing failures.
Jul 17, 2017
By BioPharm International Editors
The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.
Jul 13, 2017
By BioPharm International Editors
BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.
Jul 12, 2017
By BioPharm International Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 11, 2017
By BioPharm International Editors
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
Jul 10, 2017
By BioPharm International Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 10, 2017
By BioPharm International Editors
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
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