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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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.
July 28, 2021
FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.
July 02, 2021
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
May 12, 2021
FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.
May 10, 2021
The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.
May 02, 2021
Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.
April 21, 2021
A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.
April 20, 2021
FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.
April 16, 2021
The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.