Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

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.

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.

Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.

Stakeholders have until 30 June to comment on a set of common quality standards for mRNA vaccines that are said to be needed in light of rapid developments in this field and the emergence of novel vaccines coding for a range of specific antigens.

A study from the health technology assessment department of France’s national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies’ forward planning.

Initial data looks promising as the FDA’s pediatric oncology subcommittee is set to discuss how recent legislative changes have impacted pediatric cancer drug development. 

The Center for Drug Evaluation and Research’s new Center for Clinical Trial Innovation (C3TI) may lead a “targeted” effort to update the FDA’s regulatory framework given advances in trial design and execution, CDER Director Patrizia Cavazzoni said. Industry already has asks.

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.

A keenly-awaited legislative amendment that is expected to be adopted by the end of this year would introduce more proportionate requirements for drug sponsors to monitor the EudraVigilance database.

Sponsors can now disclose their intention of sharing deidentified individual participant data when they register a study in the EU Clinical Trials Information System. The changes are part of ongoing efforts to establish CTIS as a World Health Organization primary registry.

The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different. 

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.