Drug and biotech companies are getting nervous that CMS is creeping into the clinical trials business as cost of novel agents becomes a bigger issue.
Is the federal Medicare agency creeping into the clinical trials business? Genentech Inc. thinks they might be.
In April, the Centers for Medicare & Medicaid Services issued a proposed decision memorandum, essentially a draft guidance, revising the...
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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.
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.
Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.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 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.
