-Requires the Secretary of Health and Human Services to assess and collect fees for advisory review of direct-to-consumer television advertisements of prescription drugs.
-Medical Device User Fee Amendments of 2007: Reauthorizes the collection of medical device user fees for FY2008-FY2012. Sets forth provisions governing the inspection of medical device establishments by accredited persons.
-Pediatric Medical Device Safety and Improvement Act of 2007: Requires a person that submits an application for approval of a medical device to provide information on pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure.
-Provides special rules (Section 103) for positron emission (PET) drugs to be exempt from the annual establishment fee for some not-for-profit medical centers.
-Encourages the FDA to reconsider the termination of the Medical Imaging Drugs Advisory Committee (MIDAC).
-Requires the Secretary of HHS, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database for drugs and devices.
-Authorizes the Secretary to require a responsible person for a drug to conduct a post-approval study on the basis of scientific information.
Read the bill at:
http://thomas.loc.gov/cgi-bin/bdquery/z?d110:HR02900:
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