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© 2021 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
June 10, 2021
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
June 09, 2021
The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.
June 07, 2021
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.
June 01, 2021
Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.
May 26, 2021
FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.
May 20, 2021
FDA has responded to pressures for quick and reliable processes with multiple guidance documents and policy initiatives for updating the clinical research process.
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 06, 2021
The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.
April 30, 2021
Sponsors ignoring FDA requirements will now face stricter penalties.
April 22, 2021
White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.