There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

BIMO inspections and investigators have declined since 2017, and investigators express frustration to the Government Accountability Office that their inspection classification recommendations are downgraded by the Center for Drug Evaluation and Research.

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Novo Nordisk is expecting a relatively modest uptake in Medicare Part D for the cardiovascular claim, but plans still will worry about stemming demand in obesity.

The FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

The European Medicines Agency has published guidance on how to strengthen the supply chain for products included on the EU’s critical medicines list.

An annual meeting of Asian pharma industry groups in Tokyo recognized the need for faster joint regulatory allowance for second suppliers to stabilize the supply chain, drive e-labeling for patients and expand universal healthcare to better cover expensive therapeutics.

Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.

Five novel agents are among the user fee goal dates coming up in May 2024.

At issue is a narrow jurisdictional ruling, not the constitutionality of the Medicare price negotiation program, US attorney reminds the judges.

The UK regulator says it wants to become an ‘enabler’ of clinical trials.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

The MHRA’s regulatory strategy on AI outlines key areas where this technology could be used to improve the agency’s own processes, and says that the use of AI to develop drugs will not change the questions it asks companies.

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case.

The US Medicare Payment Advisory Commission is analyzing two of the lower-cost segments of the US medicine marketplace: generic drugs and the 340B brand discount program. In both cases, there is a picture of complexity and unintended consequences to rival higher cost segments.