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May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
May 02, 2018
Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
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.