Question |
Answer |
The Pure Food and Drug Act of 1906? |
prohibited interstate commerce in misbranded or adulterated foods and drugs |
The Food Drug & Cosmetic Act of 1938? |
required new drugs to be shown safe before marketing |
The Durham-Humphrey Amendment of 1951? |
established a clear distinction between Rx and OTC drugs |
The Kefauver-Harris Amendment of 1962? |
required new drug sponsors to show efficacy of their product prior to marketing |
The Medical Device Amendments of 1976? |
established quality control procedures for devices |
The Drug Price Competition and Patent Term Restoration Act of 1984? |
expedited the availability of generic products after patent expiration of the innovator product |
The Food and Drug Administration Modernization Act of 1997? |
established the first safe harbor for compounding by pharmacists |
The Food and Drug Administration Amendments Act of 2007? |
established Risk Evaluation and Mitigation Strategies (REMS) to assure safe use of safe drugs |
The Drug Quality and Security Act of 2013? |
created a distinction between compounding pharmacies and compounding outsourcing facilities; tract and trace requirements |
The FDA is led by who? |
a Commissioner who is appointed by the US President |
What is the goal of the Center for Drug Evaluation and Research (CDER)? |
is to promote and protect the public by assuring that all Rx and OTC are safe and effective |
What does the Office of New Drugs (OND) do? |
they are within the CDER; they are responsible for investigational studies during drug development, and making decisions regarding marketing approval for new drugs |
CDER's Office of Surveillance and Epidemiology (OSE)? |
postmarket surveillance; identify ADE that didn't appear during new drug development process. |
What are two types of misbranding? |
Commission and omission |
What is considered FDA adulterated product? |
If the product is contaminated with an unwanted substance, held in unsanitary conditions, or not manufactured, processed, packed, or held with current good manufacturing practices (cGMP) |
What is a Drug according to the FDCA? |
an article that is recognized in the United States Pharmacopeia or National Formulary and is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; intended to affect the structure of the body of man or animals |
What is dietary supplement? |
categorized as food not drug; e.g. vitamins, minerals, herbs, amino acids, enzymes, organ tissues, glandulars, and metabolites. |
What is food? |
article used for its taste, aroma, or nutritive value |
What is a device? |
an instrument, implant recognized by USP intended for use in diagnosis, cure, treatment, prevention; intended to affect the structure or function of the body |