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Authors: Richard Rettig, Jennifer Brower, Orlie Yaniv
Publisher: RAND
Keywords: defense, department, interactions, drug, administration, food, warfare, drugs, biologics, chemical, biological, acquisition
Number of Pages: 100
Published: 2003
ISBN-10: 0833034502
ISBN-13: 9780833034502

The 1990-1991 Gulf War made clear the U.S. Department of Defense

Author: Office of the Federal Register (U.S.)
Publisher: IntraWEB, LLC
Keywords: drugs, revised, april, food, title, federal, regulations, code
Number of Pages: 611
Published: 2005-06-30
ISBN-10: 0160738660
ISBN-13: 9780160738661

Title 21 presents regulations promulgated by the Food and Drug Administration, the Drug Enforcement Administration, and the Office of the National Drug Control Agency in the area of food and drugs. These regulations encompass food and drugs for human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances.

Author: Julie Somers
Publisher: DIANE Publishing
Keywords: prescription, drug, spending, medicares, drugs, using, generic, effects
Number of Pages: 36
Published: 2011-01
ISBN-10: 1437940390
ISBN-13: 9781437940398

This is a print on demand edition of a hard to find publication. Contents:(1) Overview of the Medicare Prescription Drug Benefit Program: Design of the Medicare Prescription Drug Benefit; Distribution of Spending in Medicare Part D; The Role of Private Plans in Medicare Part D; (2) Generic Drugs in Medicare Part D: Generic Substitution; Therapeutic Substitution; Comparing Potential Savings from Generic and Therapeutic Substitution; (3) Implications of Future Developments: First-Time Generic Entry; New Brand-Name Drugs; Biologics. (4) Appendix: Description of Data Used in This Analysis. Charts

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: develop, responsibilities, product, complete, estimates, needs, resource, medical, growing, administration, drug, fda, faces, meeting, challenges, food
Number of Pages: 81
Published: 2010-01
ISBN-10: 1437920705
ISBN-13: 9781437920703

Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: investigators, debarment, fda, disqualification, med, report, scope, processes, enhance, actions, clinical, needed, improve, timeliness, oversight
Number of Pages: 78
Published: 2010-03
ISBN-10: 1437924654
ISBN-13: 9781437924657

The FDA oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. This report reviewed FDA's debarment and disqualification processes. It examined the length of time that debarment and disqualification p

Author: Dan Burton
Publisher: DIANE Publishing
Keywords: security, congressional, hearing, false, protection, vaccines, force, defense
Number of Pages: 233
Published: 2001-12-01
ISBN-10: 0756718074
ISBN-13: 9780756718077

Witnesses: Sue Bailey, Assist. Sec. for Health Aff., DoD; Randall West, Spec. Assist. to the Sec. of Def. for Biol. Warfare & Anthrax, DoD; Randy Randolph, Anthrax Vaccine Immun. Prog. Agency, DoD; Cedric Dumont, Off. of Med. Serv., U.S. Dept. of State; Kathryn Zoon, Ctr. for Biologics, Eval. & Res., FDA; Kwai-Cheung Chan, Spec. Stud. & Eval., GAO, accomp. by Dr. Charla; William Crowe, Jr. (USN Ret.); Jack Melling, biol. dev't. center, the Salk Inst.; Milton Leitenberg, Center for Internat. & Security Stud., Univ. of Maryland; John Classen; Sonnie Bates, Pilot, USAF; Thomas Rempfer, Pilot, USA

Author: Steve Buyer
Publisher: DIANE Publishing
Keywords: armed, committee, services, house, representatives, hearing, avip, anthrax, defense, vaccine, immunization, program, department
Number of Pages: 157
Published: 2000-02-01
ISBN-10: 0756720974
ISBN-13: 9780756720971

Witnesses: Rudy de Leon, Dep. Sec. of Def.; Tommy Franks, Jr., U.S. Army, Commander in Chief, U.S. Central Command; Randall West, U.S. Marine Corps, Sr. Advisor to the Dep. Sec. of Def. for Chem. & Biol. Protection; J. Jarrett Clinton, Public Health Serv., 1st Assist. to the Assist. Sec. of Def. for Health Affairs; Anna Johnson-Winegar, Dep. Assist. Sec. of Def. for Chem. & Biol. Def.; Gaston Randolph, Jr., U.S. Army, Dir., AVIP; Fuad El-Hibri, CEO, Bioport Corp., accomp. by Robert Myers, Chief Scientific Officer, & Robert Kramer, CFO, Bioport Corp.; April Stephenson, Chief, Policy Programs Di
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