FDA's Drug Approval Process: Up to the Challenge? : Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, First Session, on Examining Food and Drug Administration's (FDA) Drug Approval Process, Focusing on FDA's Drug Approval Process After a Sponsor Demonstrates that Their Benefits Outweigh Their Risks for a Specific Population and Use, and that the Drug Meet [sic] Meets Standards for Safety and Efficacy, March 1, 2005 |
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AACAP adverse drug reactions adverse events Advisory Committee agency antidepressants approved drugs assess authority to require Bextra black box warning cancer CDER CHAIRMAN child and adolescent children and adolescents clinical trials companies conduct Congress consumers Cox-2 inhibitors DAVENPORT-ENNIS depression detect disease doctors drug approval process drug products drug review drug safety drug safety issues Drug Watch ensure evaluation FDA need FDA review FDA's drug important improve increase KWEDER labeling changes medical products medicines monitoring NSAIDs Office of Drug patients PDUFA pediatric percent physicians population post-marketing postmarket studies potential prescription drugs Psychiatry public health Question randomized trials regulatory safe and effective safety and efficacy safety risks safety signals scientific Scott Gottlieb Senator BURR SENATOR ENZI Senator KENNEDY Senator MURRAY side effects sponsor SSRI stroke testimony Thank therapies tients tion treatment options user fees Vioxx
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Page 42 - Now over 7,600 members strong, the AACAP is the leading national medical association dedicated to treating and improving the quality of life for the estimated 7-12 million American youth under 18 years of age who are affected by emotional, behavioral, developmental and mental disorders. AACAP supports research, continuing medical education and access to quality care. Child and adolescent psychiatrists are the only medical specialists fully trained in the treatment of mental illness in children and...
Page 80 - February 2005 joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory...
Page 10 - ... of patient and consumer groups. FDA will also increase the transparency of the Agency's decision-making process by establishing new and expanding existing communication channels to provide drug safety information to the public. These channels will help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their health care professionals to make better-informed decisions about individual treatment...
Page 10 - In addition, FDA will actively seek feedback from health care professionals, patients and consumers on how best to make this information available to them. Increased Funding for the Office of Drug Safety FDA has a longstanding commitment to provide a strong resource base for ODS.
Page 46 - References: 1) National Strategy for Suicide Prevention: Goals and Objectives for Action. Rockville, MD: US Dept. of Health and Human Services, Public Health Service, 2001. 2) Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002.
Page 10 - ... departments (eg, the National Institutes of Health and Department of Veterans Affairs). Individuals on the Board who have conducted the primary review of data or served as deciding officials for any regulatory action under consideration will be recused from voting on issues concerning those particular drugs. CDER's Deputy Director will serve as the Chair of the DSB. The DSB also will consult with other medical experts and representatives of patient and consumer groups.
Page 73 - Costle, we thank you for your real world statement, and your complete written statement without objection will be made a part of the record. Thank you very much for being here this morning.
Page 55 - Disorders, which is a nonprofit, voluntary health agency dedicated to the identification, treatment, and cure of rare diseases.
Page 44 - ... positively to the combination treatment of medication and therapy, which is a rate double the 35 percent response rate for patients on placebo. Medication, specifically antidepressants, can be helpful and even lifesaving for some adolescents, but medication is most effective when it's used as a component of a comprehensive treatment plan, individualized to the needs of the child and family. SSRI antidepressants are generally well tolerated by adolescents, and despite frequent media reports to...
Page 83 - ... defective and recalls it entirely on its own. In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply; if it does not, then FDA can seek a court order authorizing the federal government to seize the product. This cooperation between FDA and its regulated industries has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market. This method...