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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 02, 2022
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
November 02, 2021
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
September 23, 2021
Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.
September 21, 2021
US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.
August 20, 2021
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.
August 06, 2021
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
August 02, 2021
Congress questions FDA on plans to catch up and move forward with facility inspections.
July 30, 2021
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.