After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

The schedule for the second round of negotiations is different from the first cycle, in part because the Inflation Reduction Act allowed for extra time initially as the program launched. The first- and second-year timelines also overlap: The second negotiation cycle will begin before the first cycle prices are implemented. 

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

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.

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.

As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.

The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials which is for now free of charge.

Psychedelic drug developers are focusing on the US market, and there are no approvals in sight in the EU. The European Medicines Agency wants to change that.

The EMA received more than 1,000 responses to its draft reflection paper on AI in drug development, some of which will be incorporated into the final document, an agency representative told this week’s RAPS Euro Convergence 2024.

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.

The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during or right after an inspection. 

The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections, ORA chief Michael Rogers said. 

Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s regulatory history and competitive landscape when developing promotions that are consistent with FDA-labeling, experts said.

The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in the future. 

After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle cell disease drug to a level that the health technology assessment institute deems acceptable.