PharmTech Talk

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.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

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.

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.