Tech Talk

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

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

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

White House proposal includes measure to make drugs more affordable.

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.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

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

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

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

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 is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.