When FDA reviewers need help on a tricky regulatory question, they get advice from top-level officials at an internal meeting called a regulatory briefing. Many sponsors don't even know they exist. But at a time of change in review procedures and staff, companies need to learn how FDA's "internal advisory committees" work.
By Kate Rawson
Once a week, top officials from the Food & Drug Administration’s Center for Drug Evaluation & Research gather for a...
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The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.
The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
