Standards & Regulations

Dec 12, 2017
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 27, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
Manufacturers and trading partners struggle to meet drug tracking requirements
Nov 16, 2017
By Pharmaceutical Technology Editors
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
Nov 09, 2017
By Pharmaceutical Technology Editors
FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.
Nov 07, 2017
By Pharmaceutical Technology Editors
While most pharma companies are in partial production using generators, few are operating at 100% capacity.
Nov 06, 2017
By Pharmaceutical Technology Editors
The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
Nov 06, 2017
By Pharmaceutical Technology Editors
The voluntary recall is due to blister packages containing the incorrect product.
Nov 03, 2017
By Pharmaceutical Technology Editors
The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.
native1_300x100
lorem ipsum