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Articles

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.

White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Biden Budget “Wish List” Maps FDA and Health Care Priorities

Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.

Vaccine Makers Ramp Up Production, Donations to Protect IP

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.

Harmonized Lifecycle Management Policy Aims to Drive Drug Quality and Innovation

FDA has responded to pressures for quick and reliable processes with multiple guidance documents and policy initiatives for updating the clinical research process.

FDA Promotes Master Protocols to Modernize Clinical Trials

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.

FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead

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.

Pharma Prices & Patents Under Attack

Sponsors ignoring FDA requirements will now face stricter penalties.

FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results

White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.