All Patient access articles
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Industry newsFDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
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JournalHM7: First experiences with the HTA Regulation
This is a report of the HM7 session that took place at this year’s Symposium.
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JournalHM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Marie Uguen, Senior VP, Regulatory Affairs & Quality Assurance, SparingVision, France. Speakers: Laurence Campion, Regulatory Affairs Director, PTC Therapeutics France, France. Christian K. Schneider, ...
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Industry newsMHRA seals deal for fast international recognition routes
UK agency adopts recognition routes from seven national authorities; new signals start of new international framework for medicines.