Regulatory

Among FDA's diversions from accepted practices is not going “through the bureaucracy” of advisory committees for experts’ input on potential changes to improve the safety and nutrition profile of food products, says Commissioner Martin Makary.

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.

Potential for supply disruption coupled with manufacturers’ costs for moving supply chains to US emphasized by industry trade groups in comments submitted to Department of Commerce on whether pharmaceutical and dietary ingredients should remain exempted from tariffs President Trump has imposed.

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.