Tag Archives: fast-track

FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
Posted in FDA, Orphan Drugs, People, R&D, Regulatory, Strategy | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

Accelerated Approvals Could Raise Risks for Patients

By Erik Greb. FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s […]
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