The UK’s Innovative Licensing and Access Pathway (ILAP) is to enter a “new era” when it is relaunched at the beginning of 2025 with tighter entry criteria to ensure it is more closely focused on “potentially transformative” medicines, according to the drugs regulator, the MHRA.
‘New Era’ To Begin For UK’s ILAP In 2025, With Focus On ‘Transformative’ Drugs
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
More from Agency Leadership
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
• By
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
• By
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
• By
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
More from Pathways & Standards
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
• By
US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.