OR WAIT null SECS
May 02, 2018
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
April 30, 2018
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
April 24, 2018
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
April 20, 2018
A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
April 19, 2018
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.