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.

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

New poll from advocates pushing for courts and the states to stay out of FDA’s scientific decisions indicates majority of US voters support FDA drug safety determinations across party lines, though Republican support is more tentative.

US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center saw an overall increase of more than 30.

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.

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

Insurance plans put on notice that CMS is concerned about restrictions on drugs with negotiated prices, but it’s not clear what the agency can or will do about it.

As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs.

The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.

The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions. 

Guidance from the Medicines and Healthcare products Regulatory Agency says that the packaging of parallel imported medicines must make clear that they are for the UK market only.

The US FDA’s Oncologic Drugs Advisory Committee unanimously agreed that accelerated approvals should be enabled by multiple myeloma trials using MRD as a surrogate endpoint.

Dramatic transformation in the US Medicare Part D benefit design does not require any changes to CMS’ overall approach to reviewing formulary submissions from private drug plan sponsors, the agency says in its final guidance implementing the design changes for 2025.

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings, agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans, and the pending review of Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide.

After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.

The BioIndustry Association has welcomed a decision to delay the deadline for compliance with new regulations on the classification of imported materials used in drug production, but says the border rules are still not proportionate for life science products.

A new center for personalized medicine in Estonia will see PacBio’s long-read whole genome sequencing technology used to unlock new information about how genetics impact patients’ drug responses, experts from the project tell the Pink Sheet.