FDA REGULATIONS EXAM QUESTIONS

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FDA REGULATIONS EXAM QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -48 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: Federal Drug Administration Modernization Act 1997

(FDAMA 1997)

stakeholders (everyone who had an interest in what happened)

Answer:

Appropriate scientific and academic experts Health care professionals Representatives of patient and consumer advocacy groups Regulatory industry

Question 2: 1st Act instituted on purely economic basis

Answer:

1984 Waxman-Hatch Act Drug Price Competition and Patent Term Restoration Act of 1984 Question 3: Orphan drugs:

Answer:

Treat rare diseases which affect <200,000 persons in US Treat rare diseases which affect >200,000 persons in US but for which there is no reasonable expectation that the cost of development and making drug available in US will be recovered from US drug sales

Question 4: problem with Sherley Amendment

Answer:

Difficult to enforce Must prove defendant had fraudulent intent Protected by claiming ignorance (they can say oh i thought it worked) Safety?

Question 5: desrice major reforms of FDAMA (4)

Answer:

Compounding PDUFA Dissemination of Off-label use HCEI

Question 6: 1962 Harris-Kefauver Amendment

Answer:

Drug Efficacy and Safety Implementation (DESI) ---Required drugs marketed 1938-1962 to prove efficacy in addition to safety -Required manufacturers of generic drugs marketed after 1938 to complete abbreviated new drug application (ANDA) - requires bioequivalency data

Question 7: provisions of 1938 The Federal Food Drug and Cosmetic (FDC) Act

Answer:

False claims could be stopped without proving intend to defraud (Eliminated Sherley Amendment) ***adequate directions for use and warning safety testing prior to marketing applies to cosmetics and medical devices

Question 8: PDUFA 1992

Answer:

(pronounced Pah DEW fah) Enacted 1992, then renewed every 5 years (FDAMA) Authorized FDA to collect user fees for certain applications for approval of human drugs and biological products (Rx drugs) User fees - augment FDA's resources devoted to review of human drug applications Aim to eliminate back logs of drug applications

http://www.fda.gov/oc/pdufa/

Question 9: As part of the Dept of Health and Human Services (DHHS) the FDA is:

Answer:

Public Health Agency charged with promoting and protecting American Consumers by enforcing FFD&C Act Oldest consumer protection agency in US FDA decisions affect virtually every American every day Regulates >$2 trillion worth of products or > 20 % of all consumer expenditures

Question 10: FDAMA objective (5)

Answer:

• Maximize availability and clarity of information about Agency application and submission review

process for consumers and patients

• Post-marketing monitoring provisions
• Access to scientific expertise
• Establish mechanisms for meeting specified review periods of applications and submissions
• Eliminate back logs in review of applications

Question 11: The Pure Food and Drug Act 1906 did not (5)

Answer:

did not give government authority to set standards of purity or ban unsafe drugs did not extend to cosmetics or devices did not consider false therapeutic or efficacy claims about a drug as misbranding Newspaper ads "cancer cure"

did not require manufacturers to label:

list ingredients, directions, warnings

Question 12: compounding reform of FDAMA not allowed

Answer:

Not allowed ---Soliciting business (promoting, advertising) to compound specific drug product classes or therapeutic classes ---Compounding regularly or inordinate amounts of drug products that are already available in the marketplace (generic copies) ---Using commercial scale manufacturing equipment for compounding

Question 13: FDA is responsible for

Answer:

protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation (e.g. TSA full body security scanners, microwave ovens, cell phones).

advancing public health by helping to speed innovations that make medicines and foods more effective, safer, and affordable; helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.for regulating the manufacturing, marketing and distribution of tobacco products

Question 14: 1962 Harris-Kefauver Amendment

aka Drug efficacy amendment

Answer:

Thalidomide Tragedy --Tranquillizer available in Germany (3 yrs) w/o Rx --Considered very safe --Teratogenic - phocomelia ------1000s of babies affected in Europe --Aroused public support for stronger drug regulation --"Drug Efficacy Amendment"

Question 15: provisions of 1983 Orphan Drug Act

Answer:

For years recognized that NDA process was too expensive to warrant innovation of Rx for rare disease Before the passage of the ODA the FDA did not have any mission to promote drug therapy for rare diseases Enabled FDA to promote R&D of drugs (orphan drugs) treating "rare diseases and conditions" 25 million Americans with 1 of 7,000 'rare diseases'

Question 16: 1951 Durham-Humphrey Amendment guidelines

Answer:

Guidelines for Prescription Drugs Hypnotic or habit forming Drug not safe for self medication because of toxicity or potentially harmful effects A new drug that has not been shown to be safe for use in self-medication

Question 17: 4. Promotion of Health Care Economic Information (HCEI) caveats

Answer:

HC information must relate to approved use Dissemination is limited -Formulary committees -MCO -Large scale buyers of HC information -not individual MDs or patients