The statement outlining opioid priorities in the FDA’s FY 2022 budget request comes on the heals of Sen. Manchin’s criticism of the acting commissioner and FDA opioid policy.

The UK is on a mission to re-join the International Council for Harmonisation as a fully active member with voting rights.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Sens. Durbin and Grassley hope report will help revive their flagging legislation that would require Rx ads to include list prices Senators claim that the Government Accountability Office concludes that direct-to-consumer spots for prescription drugs drives ‘drastic’ increases in Medicare costs.

To improve common standards for global development for generics and access to generics, FDA has launched the Generic Drug Cluster through the Global Generic Drug Affairs team established by the FDA’s Office of Generic Drugs. The agency has listed objectives through which it aims to increase scientific alignment among leading generic drug regulatory agencies. 

US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.

Stakeholders discuss network models, barriers to their creation, and what is needed for them to be successful at PhRMA meeting.

Sens. Durbin and Grassley hope report will help revive their flagging legislation that would require Rx ads to include list prices Senators claim that the Government Accountability Office concludes that direct-to-consumer spots for prescription drugs drives ‘drastic’ increases in Medicare costs.

Existing value-based contracts, which are voluntary for manufacturers, do not lower costs for states, National Association of Medicaid Directors executive director Matt Salo suggests.

US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Investors are trying to wrap their minds around exactly how big Pfizer’s COVID vaccine business will end up being. But they also have questions about Pfizer’s prospects at the opposite end of the patient-population spectrum.

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains.