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In the United States, every medicine is rigorously tested and approved for safety and efficacy before entering the market, ensuring American patients with one of the most secure drug supplies in the world. In 2003, there were more than 370 biotech drug products and vaccines in clinical trials targeting more than 200 diseases, including various cancers, Alzheimer's disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis.
However, many health-care advocates agree that the current system for clinical trials needs reform. The problems range from overworked Institutional Review Boards to a confusing patchwork of state and federal laws that make multicenter trials difficult to plan and execute. Because the integrity and efficiency of clinical trials is of the utmost importance to biotech companies developing biomedical products, BIO has been a leading advocate for patient safety, privacy, and a single set of federal laws to provide consistency across the United States. BIO will never compromise our high ethical standards for clinical investigations.
BIO Statement
On Protecting Research and Research Participants.
Read the statement
EMEA's draft guideline "The Requirements for First-in-Human Clinical Trials for Potential High Risk Medicinal Products" (May 23, 2007)
BIO comments to the European Medicines Agency
Read the comments (151 KB PDF)
Comments on Draft Guidance on Computerized Systems in Clinical Trials
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240). (January 5, 2005)
Read the comments. (283 KB PDF)
BIO's Comments to FDA's Proposed Rule on Institutional Review Board (IRB) Registration Requirements
Docket No. 2004N-0242, Federal Register: July 6, 2004 (Volume 69, Number 128, pp. 40556-40562).
Read the comments. (100 KB PDF)
Comments on Proposed Rule on Human Subject Protection
Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application: FDA Docket No. 2004N-0018. (September 8, 2004)
Read BIO's comments.
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