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February 23, 2024
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
February 09, 2024
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
January 02, 2024
Revolutionary therapies restructure pharmaceutical manufacturing.
December 01, 2023
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
November 09, 2023
The document includes recommendations for the reporting and implementation of changes to container closure system components.
November 03, 2023
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.
November 01, 2023
USP offers strategies to minimize residual impurities in downstream processing.
October 11, 2023
The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
October 05, 2023
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.