FDA's Expedited Drug Programs

Analysis, Postmarket Monitoring & Industry Guidance

Buch | Softcover

100 Seiten

2016
Nova Science Publishers Inc (Verlag)
978-1-63485-772-7 (ISBN)

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The Food and Drug Administration (FDA) oversees the safety and effectiveness of drugs sold on the U.S. market. When there is an unmet need for the treatment of a serious condition, FDA may use one or more of its expedited programs, such as fast track and breakthrough therapy designation, which are intended to bring drugs to market more quickly. FDA is also responsible for monitoring the safety of drugs and reporting on those efforts. This book examines the number and types of requests for fast track or breakthrough therapy designation; the number and types of FDA-approved drug applications that used an expedited program; and the extent to which FDAs data on tracked safety issues and postmarket studies allowed the agency to meet its reporting and oversight responsibilities.

Preface; Drug Safety: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement; Statement of Janet Woodcock, Director, Center for Drug Evaluation & Research, Food & Drug Administration. Hearing on ''21st Century Cures: Incorporating the Patient Perspective''; Guidance for Industry: Expedited Programs for Serious Conditions Drugs & Biologics; Index.

Erscheinungsdatum	07.09.2016
Verlagsort	New York
Sprache	englisch
Maße	155 x 230 mm
Gewicht	184 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
ISBN-10	1-63485-772-0 / 1634857720
ISBN-13	978-1-63485-772-7 / 9781634857727
Zustand	Neuware