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Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.
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Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Pediatrics --- Drug approval


Book
Guidance for industry : accelerated approval products, submission of promotional materials.
Authors: ---
Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Drug approval --- Advertising --- Drugs


Book
Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.
Authors: ---
Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Abstract

Keywords

Pediatrics --- Drug approval


Book
Guidance for industry : accelerated approval products, submission of promotional materials.
Authors: ---
Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Drug approval --- Advertising --- Drugs


Book
Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use"
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Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,

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Book
Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use"
Author:
Year: 1999 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,

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Preparing for FDA pre-approval inspections
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ISBN: 0824702182 9780824702182 Year: 1999 Publisher: New York : Marcel Dekker,

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"This one-of-a-kind reference clarifies FDA requirements for the manufacture of clinical trial material as well as product development activities and suggests strategies that will facilitate FDA authorization to market." "Featuring key bibliographic references, tables, and drawings, Preparing for FDA Pre-Approval Inspections will be prized by pharmaceutical scientists, manufacturers, and engineers; drug quality assurance, quality control, and regulatory personnel; and pharmacologists."--Jacket.

La médecine des preuves : histoire et antropologie des essais cliniques, 1900-1990
Authors: ---
ISBN: 2843240441 Year: 1999 Publisher: Essonne : Synthélabo,


Periodical
Drugs in R & D.
ISSN: 11745886 11796901 Year: 1999 Publisher: [Mairangi Bay, Auckland, N.Z.] : Adis International,

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Keywords

Drug Evaluation --- Drug Industry --- Drugs, Investigational --- Research --- Drugs --- Pharmacology --- Drug development --- Médicaments --- Pharmacologie --- Periodicals. --- Testing --- Périodiques --- Développement --- Essais cliniques --- Drug Evaluation. --- Drug Industry. --- Drugs, Investigational. --- Research. --- Drug development. --- Drugs. --- Pharmacology. --- Testing. --- Chemistry --- Health Sciences --- Biochemistry --- Pharmacy and Pharmacology --- pharmacology --- drug development --- drug research --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Pharmacy --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Materia medica --- Development of drugs --- New drug development --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Laboratory Research --- Research Activities --- Research and Development --- Research Priorities --- Activities, Research --- Activity, Research --- Development and Research --- Priorities, Research --- Priority, Research --- Research Activity --- Research Priority --- Research, Laboratory --- Ethics, Research --- Investigational Drugs --- Investigational New Drugs --- Drugs, Investigational New --- New Drugs, Investigational --- Drug Approval --- Industries, Pharmaceutic --- Industry, Drug --- Industry, Pharmaceutic --- Industry, Pharmaceutical --- Pharmaceutical Industry --- Drug Industries --- Industries, Drug --- Industries, Pharmaceutical --- Pharmaceutic Industries --- Pharmaceutic Industry --- Pharmaceutical Industries --- Drug Evaluation Studies --- Evaluation Studies, Drug --- Drug Evaluation Study --- Drug Evaluations --- Evaluation Study, Drug --- Evaluation, Drug --- Evaluations, Drug --- Studies, Drug Evaluation --- Study, Drug Evaluation --- Physiological effect --- Development --- Clinical trials --- Effectiveness --- Evaluation --- Pharmacology. Therapy --- farmacologie --- Investigational Drug --- Investigational New Drug --- Drug, Investigational --- Drug, Investigational New --- New Drug, Investigational

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