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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
July 28, 2021
FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.
July 16, 2021
The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.
July 15, 2021
As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
July 14, 2021
White House proposal includes measure to make drugs more affordable.
July 01, 2021
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.
June 22, 2021
FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.
June 21, 2021
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.
June 14, 2021
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.