Standards & Regulation

Aug 24, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
Aug 24, 2015
The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.
Aug 19, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
Aug 18, 2015
Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
Aug 17, 2015
By Pharmaceutical Technology Editors
FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.
Aug 17, 2015
By Pharmaceutical Technology Editors
The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.
Aug 14, 2015
By Pharmaceutical Technology Editors
The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Aug 11, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The agency issues guidance for companies considering registering with FDA as an outsourcing facility.
Aug 03, 2015
By Pharmaceutical Technology Editors
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
Aug 03, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.