Standards & Regulations

Jun 16, 2017
By BioPharm International Editors
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
Jun 15, 2017
Congressional measures lack the support to move forward.
Jun 14, 2017
By BioPharm International Editors
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
Jun 14, 2017
By BioPharm International Editors
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.
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.
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