Prescription Drug Product Submissions Flashcards
Public Health Service Act of 1944
a
Federal Food, Drug, and Cosmetic Act of 1938
a
Drug Price Competition and Patent Term Restoration Act of 1984
Hatch-Waxman Act -
Prescription Drug Marketing Act of 1987
a
Prescription Drug User Fee Act of 1992
PDUFA
Federal Advisory Committee Act of 1972
a
Food and Drug Administration Modernization Act of 1997
FDAMA
Food and Drug Administration Amendments Act of 2007
FDAAA - If FDA becomes aware of new safety information about a serious risk associated with a drug’s use, the agency can require a manufacturer to implement safety labeling changes, conduct postmarketig studies or clinical trials, or establish Risk Evaluation and Mitigation Strategies (REMS)
Food and Drug Administration Safety and Innovation Act of 2012
FDASIA
21 CFR 314
Applications for FDA approval to market a new drug
21 CFR 601
Licensing (biological products)
Target Product Profile
TPP - is a format for a summary of the drug development program described in term of labeling concepts. It is prepared by the sponsor and submission is voluntary. It links each specific labeling concept to a specific study or other source of data that is intended to support the labeling concept.
Drug Development Tools
DDT - animal models, biological marker and clinical outcomes assessments (COAs)
Breakthrough Therapy Designation
FDASIA made available to expedite the development of therapies that show substantial promise in early clinical trials. Drug needs to be for a serious and life-threatening disease, and preliminary clinical evidence shows the drug may offer substantial improvement over existing therapies.
Priority Review
Given to drugs that offer major advances in treatment, or provide treatment where no adequate therapy exists. FDA reviews more quickly than standard applications. Fast Track are also eligible for Priority Review but does not automatically convey a Priority Reivew. Applicant must request it