Jill Wechsler, Pharm Exec’s Washington Correspondent

FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into submissions to the agency, while addressing concerns about its relevance and reliability.

Changes prompt collaboration and improved quality management.

Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.

Critics say FDA is either acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.

If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.

FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.

Democrats failed to gain sufficient support this week to advance long-debated legislation to permit Medicare drug price negotiations.

But accelerated approval program faces scrutiny.

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.

White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the U.S. and globally.

Legislative proposals for curbing outlays on prescription drugs have moved to center stage, as Congress looks hard for ways to pay for costly initiatives to repair the nation’s infrastructure, offset global warming and expand health care programs.

FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.

FDA has granted full approval for the Pfizer/BioNTech anti-COVID 19 vaccine, raising hopes that this action will help overcome the vaccine hesitancy that has plagued efforts to broadly immunize the U.S. population.

While biopharma companies will pay more than $3 million to file an NDA or BLA application during fiscal year 2022, new fees for generic drugs will see modest or no increases and those for biosimilars may drop or hold even.

The White House is looking to pay for some of its prime social and health initiatives by reducing outlays for prescription drugs, according to an announcement by President Biden.

All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.

FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.

FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.

A broad White House proposal to advance competition in major U.S. industries features several measures intended to make medicines more affordable for patients.

FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.

CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.

FDA’s surprise decision this week to approve Biogen’s treatment for Alzheimer’s Disease has raised serious questions about the validity and value of the agency’s accelerated approval process.

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

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

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

FDA’s Q12 standard, crafted by members of the ICH, aims to help manufacturers manage changes in chemistry, manufacturing and controls of marketed drugs and biologics to encourage continual improvement in biopharmaceutical production.

FDA expects to conduct only a small portion of scheduled facility visits this year due to continued limitations on travel imposed by the COVID-19 pandemic

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.

A NASEM report for CDER outlines strategies to modernize pharmaceutical manufacturing to ensure reliable access to high-quality drugs, particularly in response to disruptions caused by the pandemic.

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