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Author: Janet Heinrich
Publisher: DIANE Publishing
Keywords: drugs, selected, pipeline, approval, affected, factors, prescription, fda
Number of Pages: 62
Published: 2000-01
ISBN-10: 0756708095
ISBN-13: 9780756708092

Legislation was recently introduced to institute a process by which the manufacturers of pipeline drugs (PD) that took longer than 5 years to be approved & whose patents were still in effect could apply for a patent extension. 7 of the 122 PD would be eligible for review under this proposal. This report examines FDA review & approval (R&A) of the manufacturers' applications to market 7 drugs that would be covered by the proposed legislation. It examined: the R&A times for the 7 PD in comparison with other drugs & the factors that contributed to the time FDA required to approve the 3 of the 7 d

Author: Marcia Crosse
Publisher: DIANE Publishing
Keywords: pharmaceuticals, children, conducted, studies, drug, research, pediatric
Number of Pages: 60
Published: 2007-08
ISBN-10: 1422317161
ISBN-13: 9781422317167

About 2/3 of drugs prescribed for children have not been studied & labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharm. for Children Act (BPCA), encourages the mfrs. of drugs that still have marketing exclusivity to conduct pediatric drug studies (PDS), as requested by the FDA. If they do so, FDA may extend for 6 mo. the period during which no equivalent generic drugs can be marketed. This report: assessed the extent to which PDS were being conducted under BPCA for on-patent drugs; evaluated the impact of BPCA o

Author: Unknown
Publisher: DIANE Publishing
Keywords: drugs, fight, winning
Number of Pages: 86
Published: 1994-01-01
ISBN-10: 0788102729
ISBN-13: 9780788102721

Describes the resources available to fight illegal drugs in public housing communities across the U.S. Covers: screening the applicant, using the lease's provisions, evictions, physical and management improvements, drug-free workplaces, resident initiatives against drugs, case examples, and resources. B/W photos.

Author: Roundtable for the Development of Drugs and Vaccin
Publisher: National Academies
Keywords: aids, september, conference, summary, infection, hiv, endpoints, evaluating, effectiveness, drugs, surrogate
Number of Pages: 28
Published: 1990
eBookDB-ID: NAP:13448

Author: Unknown
Publisher: DIANE Publishing
Keywords: guide, prevention, parent, free, drug, growing
Number of Pages: 52
Published: 1989-12
ISBN-10: 0788100696
ISBN-13: 9780788100697

Shows parents what children should know about drugs, including alcohol and tobacco, at each age level. Special section on specific drugs and their effects, including alcohol, tobacco, cannabis, inhalants, cocaine, other stimulants, depressants, hallucinogens, narcotics, designer drugs, and anabolic steroids. Contents: teaching values; getting the facts; talking with and listening to your child; communication tips; teaching your child to say No; what to do if your child is using drugs; school-parent cooperation; parent support groups, and more. Photos and children's art.

Author: James C. Cosgrove (au)
Publisher: DIANE Publishing
Keywords: ensure, included, drugs, availability, quality, data, monitoring, oral, certain, esrd, disease, renal, cms, assess, payment, adequacy, stage
Number of Pages: 44
Published: 2011-06-01
ISBN-10: 1437983510
ISBN-13: 9781437983517

For most individuals with ESRD, Medicare purchases a bundle of dialysis-related services using a single payment. In 2014, CMS plans to include in this bundled payment "oral-only" ESRD drugs used to treat mineral and bone disorder. This report: (1) describes the rationales for including oral-only ESRD drugs in the bundled payment; (2) examines dialysis organizations' recent experience providing oral-only ESRD drugs and their future ability to provide these drugs; (3) examines the data sources that CMS could use to account for oral-only ESRD drugs in the bundled payment; and (4) examines CMS's a

Author: United States, General Accounting Office, Educatio
Publisher: DIANE Publishing
Keywords: drugs, pipeline, report, requesters, selected, congressional, approval, factors, affected, fda, prescription
Number of Pages: 58
ISBN-10: 1428972536
ISBN-13: 9781428972537
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