Rac chapter 1 fda - Study guides, Class notes & Summaries

RAC Chapter 3 Test Questions and Answers All Correct Fast Track Designation - Answer- 21 CFR 312 defines a serious disease as ' a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity wii usually not be sufficient, but the morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgement, based on its impact on such factors as...

RAC Chapter 1 - FDA and related regulatory agencies Exam Questions and Answers

RAC Chapter 18N (15)- OTC Drug Products Questions And Answers In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - ANS-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - ANS-• benefits clearly outweigh pos...

FDA Adverse Event Reporting - RAC US 5 day Report - ANS->803.53 (Device) 5 work days after the day that you become aware that: (a) An MEDICAL DEVICE REPORTING (MDR) reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis; or (b) We (The FDA) have made a written request for the submission of a 5-day report. If you recei...

Decision Tree - Answer-1.Drug,Device or Some Combination - For human use -drug - new drug = New NDA Route 505(b)(1) 2.Drug,Device or Some Combination- For human use -drug- NOT new drug- same formulation as RLD=ANDA Route 3. Drug,Device or Some Combination- For human use -drug- not new drug- NOT same formulation as RLD- Right of reference to original NDA=NDA Supplement ( same formulation, new indication, new route) 4. Drug,Device or Some Combination- For human use -drug- not new drug- NOT sa...

FDA is under? - Answer-Department of health and human services (DHHS) FDA regulates what types of products? - Answer-Food, dietary supplements, cosmetics, vet products, drugs, med devices, biologics, tobacco, vaping Statute vs regulation vs Guidance - Answer-Statute is a law passed by congress, regulation is a rule issued by a federal agency, guidance is the FDA's current thinking on its regulations Biologics control act - Answer-1901 law regulating vaccines, serums and antibodies F...