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Was (wer) ist FDA$27628$ - definition
US FDA DESIGNATION FOR INVESTIGATIONAL DRUGS
FDA Fast Track; Fast Track Designation; FDA Fast Track Development Program; Fast Track (FDA); Fast track status; Fast track designation
FDA preemption
LEGAL THEORY IN THE UNITED STATES THAT EXEMPTS PRODUCT MANUFACTURERS FROM TORT CLAIMS REGARDING FOOD AND DRUG ADMINISTRATION APPROVED PRODUCTS
FDA Preemption
FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). It has been a highly-contentious issue.
FDA warning letter
FDA Warning Letter
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
Fast track (FDA)
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company.
Wikipedia
Fast track (FDA)
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.
