Standards & Regulation

Pharmaceutical Technology: Apr 17, 2015
WHO says that results from clinical trials should be reported within 12 months of completion of the study
Pharmaceutical Technology: Apr 16, 2015
By Pharmaceutical Technology Editors
At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.
Pharmaceutical Technology: Apr 16, 2015
By Pharmaceutical Technology Editors
The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.
Pharmaceutical Technology: Apr 16, 2015
By Pharmaceutical Technology Editors
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
Pharmaceutical Technology: Apr 14, 2015
By Pharmaceutical Technology Editors
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
Pharmaceutical Technology: Apr 13, 2015
By Pharmaceutical Technology Editors
Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.
Pharmaceutical Technology: Apr 10, 2015
By Pharmaceutical Technology Editors
FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.
Pharmaceutical Technology: Apr 02, 2015
More reliable operations would accelerate product development and prevent drug shortages.
Pharmaceutical Technology: Apr 02, 2015
Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?
Pharmaceutical Technology: Apr 02, 2015
Industry awaits the final revision of USP General Chapter <1207> and the impact it will have on the evaluation of sterile product package integrity.