Standards & Regulations

Jun 14, 2017
By BioPharm International Editors
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
Jun 12, 2017
By BioPharm International Editors
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
Jun 09, 2017
By BioPharm International Editors
In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
Jun 08, 2017
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
Jun 06, 2017
By BioPharm International Editors
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
Jun 02, 2017
By BioPharm International Editors
The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
Jun 02, 2017
By BioPharm International Editors
The agency published an action plan to nurture innovation and drug development by SMEs.
Jun 01, 2017
BioPharm International
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
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.
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