I need helping answering the the following questions for a quiz study guide for
ID: 244591 • Letter: I
Question
I need helping answering the the following questions for a quiz study guide for public health
1.)Identify two other categories of products besides foods and drugs regulated by the FDA.
2.) Describe recent changes in the FDA laws for food and also for drugs
3.) Describe the role of post-market surveillance in drug safety
4.)Explain the safety limitations of traditional approaches to drug approval
5.)Describe the phases of drug approval by the FDA
6.)Identify the roles played by the FDA, CDC, and the U.S. Department of Agriculture in food safety
7.)Identify the steps in a foodborne outbreak investigation.
8.)Describe six ways that food affects health and disease.
Explanation / Answer
And) FDA regulates:
- Foods, dietary supplements, human drugs, vaccines, blood products, other biologics, medical devices, electronic products, cosmetics, vet products
2) The FDA Safety and Innovation Act of 2012
FDASIA - reauthorized the prescription drug user fee act: adds new user fees for generic drugs and biosimilars. There are also portions of the law designed to decrease drug counterfeiting by blocking drug imports of adulterated products, detecting and reducing drug shortages and enhancing the exchange of drug diversion information across state lines.
3) The role of post-market surveillance in drug safety is to protect the innovator product by allowing limited market exclusivity through intellectual property rights (IPR)
2 main effects of intellectual property rights (IPR):
• Provide incentives for innovative drug development
• Allow companies to control the market (get a higher price)
4) Safety limitations to drug approval:
FDA Prescription Drug Labeling
• Federal Regulations: 21 CFR 201.56
Contain a summary of essential scientific information for the safe and effective use of the drug is informative and accurate, uses language that is not promotional in tone, false, or misleading
No false claims