Standards & Regulation

Pharmaceutical Technology: Jan 26, 2015
By PharmTech Editors
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
Pharmaceutical Technology: Jan 26, 2015
By PharmTech Editors
The agency creates an electronic central repository to facilitate drug safety assessment reports.
Pharmaceutical Technology: Jan 26, 2015
By PharmTech Editors
Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.
Pharmaceutical Technology: Jan 23, 2015
By PharmTech Editors
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
Jan 23, 2015
By PharmTech Editors
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
Jan 23, 2015
By PharmTech Editors
A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.
Pharmaceutical Technology: Jan 21, 2015
By PharmTech Editors
The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.
Pharmaceutical Technology: Jan 20, 2015
FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.
Pharmaceutical Technology: Jan 19, 2015
By PharmTech Editors
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
Jan 15, 2015
By PharmTech Editors
USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.