THE FOOD DRUG ADMINISTRATION FDA EXAM

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QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -15 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: What does the FDA do?

Answer:

5 major activities:

• New product review

• Keeping watch

• Standards & regulations

• Research

• Enforcement/Correcting Problems

Question 2: What does the FDA cover?

Answer:

-Food -Medicines, biologics, & medical devices -Consumer & medical products -Animal drugs -Cosmetics -True & informative labels

Question 3: The FDA Review Process

Answer:

-Some products, such as new drugs & complex medical devices, must be proven safe & effective before they can be marketed -Other products such as x-ray machines and microwaves, must simply meet certain performance standards.-Once a product gains FDA approval, it must continue to meet FDA standards while on the market -The guiding principle is whether the benefit outweighs the risks (no product is 100% risk free)

Question 4: FDA Laws

Answer:

-1862: Bureau of Chemistry formed

-1883: Dr. Harvey Wiley becomes head of Bureau of Chemistry

-Food & Drugs Act of 1906 -1927: Food, Drug, & Insecticide Administration created out of Bureau of Chemistry -Federal Food, Drug, & Cosmetic Act of 1938

Question 5: Surveillance & Inspection

Answer:

-Inspects manufacturers -Checks import shipments -Test for contamination Reviews problem reports for products after they are marketed (over 400,000 problem reports each year)

Question 6: FDA Review Process

Answer:

-New Drug Application (NDA) -Safe & effective = "approvable" -"Letter of Approval"

Question 7: FDA Enforcement

Answer:

-Recall & field correction: class I recall, class II recall, class III recall -Medical Device Notification or Safety Alert -Injunction -Seizure -Prosecution

Question 8: Food & Drug Administration

Answer:

-One of the nation's oldest & most respected consumer protection agencies -FDA regulated products account for 25 cents out of every $1 spent by consumers -The FDA costs each American just over a penny a day

Question 9: The FDA Center for Drug Evaluation & Research (CDER)

Answer:

-Evaluates all new drugs for safety and effectiveness -Drug review time reduced to less than one year -Terrorism and the FDA

-2001: 66 new drugs approved

Gleevac: record 2.5 month approval

Question 10: Standards & Regulations

Answer:

The FDA creates regulations and product standards:

-to assure product safety -to provide accurate information

Question 11: FDA Center for Devices and Radiological Health (CDRH)

Answer:

-Evaluates new medical devices for safety & effectiveness -Ensures consumer products meet radiation safety standards -CDRH has streamlined its review processes and reduced the average time from 26 months to 12 months

Question 12: Why do we have the FDA?

Answer:

-Misbranded & adulterated food -Cure-alls, tonics, and "patent" medicines -Chemicals, preservatives, and toxic food coloring -The "Poison Squad" -Upton Sinclair's The Jungle -Elixir of Sulfanilamide

Question 13: Enforcement/Correcting Problems

Answer:

Actions to protect the public health:

-manufacturer recall -injunction -seizure -withdraw drug approval -require labeling changes -send out warnings

Question 14: New Product Review

Answer:

-Does NOT develop or test products itself -Reviews the results of company testing -What has to be reviewed?

Question 15: Research

Answer:

-Provides scientific basis for its regulatory decisions -Identifies risks caused by products -Develops standards -Evaluate new products -Study emerging risks