Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’
The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.
ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.
Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs
US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot
Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population.
It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
340B Hospitals Charging Private Insurers Nearly Four Times Acquisition Costs On Cancer Drugs – Study
New report makes a case for further scrutiny of the 340B program's contributions to high drug costs, although manufacturers remain the main target of legislative and regulatory reform proposals.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.