OR WAIT null SECS
November 28, 2016
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
November 17, 2016
At ICH’s November 2016 meeting, the council announced new members and new guidelines.
The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
November 11, 2016
The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.
November 09, 2016
What’s ahead for the healthcare and pharmaceutical industries?
November 03, 2016
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
November 02, 2016
Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.
November 01, 2016
Douglas C. Throckmorton, MD, provides some key facts about abuse-deterrent opioids.
October 18, 2016
The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.