Standards & Regulation

Jun 14, 2017
By Pharmaceutical Technology 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 Pharmaceutical Technology Editors
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
Jun 09, 2017
By Pharmaceutical Technology 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 Pharmaceutical Technology Editors
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
Jun 02, 2017
Pharmaceutical Technology
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 02, 2017
Pharmaceutical Technology
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Jun 02, 2017
Pharmaceutical Technology
Approval of breakthrough therapies requires expedited quality assessment.
Jun 02, 2017
By Pharmaceutical Technology Editors
The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.
Jun 02, 2017
By Pharmaceutical Technology Editors
The agency published an action plan to nurture innovation and drug development by SMEs.
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