Food and Drug Administration Amendments Act of 2007

Summary

Food and Drug Administration Amendments Act of 2007 - Prescription Drug User Fee Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize the collection of prescription drug user fees for FY2008-FY2012. 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. Pediatric Research Equity Act of 2007 - Sets forth conditions under which the Secretary may grant waivers or deferrals of requirements that applicants submit a pediatric assessment for new drugs and biological products. Best Pharmaceuticals for Children Act of 2007 - Makes changes to provisions regarding market exclusivity for conducting pediatric drug studies on new or already approved drugs. Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the Food and Drug Administration (FDA) to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Provides for recruitment of potential members of FDA advisory committees. Requires the Secretary, 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

10 official files

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 16 July 2007

  ViewDownloadOpen at official source

• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 16 July 2007

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 11 July 2007

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 11 July 2007

  ViewDownloadOpen at official source

• Reported in House (text)

  Reported in House · EN · 11 July 2007

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 11 July 2007

  ViewDownloadOpen at official source

• Passed House amended

  summary · EN · 11 July 2007

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 28 June 2007

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 June 2007

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 28 June 2007

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.