Compassionate Use of Investigational New Drugs: Is the Current Process Effective? : Hearing Before the Committee on Government Reform, House of Representatives, One Hundred Seventh Congress, First Session, June 20, 2001 |
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Abigail access to experimental ANN DAVIS approval process AstraZenica Barr Baxter breast cancer Burroughs BURTON cancer patients Chairman chemotherapy Christakis clinical trials colon cancer colorectal cancer Committee compassionate use program Dan Burton David David's doctor DAVIS OF VIRGINIA DELANEY diagnosed disease drug available drug companies drug development early access programs effect expanded access experimental drugs experimental treatments FDA approval FDA's formulated prognosis Foundation frank disclosure give going Government Reform hearing hope hospice ImClone Systems investigational drugs IRESSA issue JO ANN DAVIS Kellum Lamont manufacturing needs oncologist oncology optimistic OSI Pharmaceuticals patients with cancer pessimistically discrepant phase physicians PMID prognoses Prognostic Disclosure protocol question requests safety Samuel Waksal Santino single patient IND sponsor survival estimates talking tell TEMPLE terminally ill Thank things tients treated treatment IND tumor WAKSAL WELDON
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Page 108 - by expediting their development, review and approval. All of these programs have been instrumental in shortening the time to marketing approval for cancer drugs and biologies. FDA programs include: Expedited development under Title 21, Code of Federal Regulations (CFR) Part 312, Subpart E expedites the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses.
Page 110 - (2) Accessibility (listening to the caller's concerns and giving him or her as much time as he or she needs); (3) Education (about the drug approval process and his or her options); and (4) Assistance (providing additional information to the patient or family member that may be helpful, eg other sources of information).
Page 17 - The Coalition's main goals are to increase federal funding for breast cancer research and collaborate with the scientific community to implement new models of research; improve access to high quality health care and
Page 96 - aware of the impact FDA's processes and decisions have on the public we serve. Under the Federal Food, Drug, and Cosmetic (FD&C) Act and related statutes, the Government has a vitally important role in helping to ensure that the
Page 102 - what happens to a drug in the human body, how it is changed (metabolized), how much of it (or a metabolite) gets into the blood and various organs, how long it stays in the body, and
Page 102 - Before clinical testing begins, researchers analyze the drug's main physical and chemical properties in the laboratory and study its pharmacologic and toxic effects in laboratory animals (pre-clinical studies). If the laboratory and animal study results show promise, the sponsor
Page 17 - Dan Burton Committee on Government Reform 2157 Rayburn House Office Building Washington, DC 20515 Dear Chairman Burton: On behalf of the
Page 104 - in advance by the people conducting the trial and patients must agree to the conditions before they can participate. The hope of personally benefiting from a new drug, or the desire to take part in research
Page 107 - included: 1) expediting approval of cancer therapies; 2) encouraging new uses of marketed products in cancer treatment; 3) expanding access to investigational cancer therapies that have been approved in other countries; and 4)