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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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 06, 2021
The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.
An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.
July 02, 2021
Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.
New challenges arise in extractable and leachable studies for cell and gene therapy products.
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.
The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.
July 01, 2021
With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
June 22, 2021
FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.