Fda definition of a drug - Study guides, Class notes & Summaries

FDA-reportable ADE correct answer: For reporting an ADE to the FDA, the FDA defines ADEs as serious adverse events related to drugs or devices in which "the patient outcome is death, life threatening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent, or permanent), congenital anomaly, or required intervention to prevent permanent impairment or damage. Reportable serious ADEs to the FDA may include: a. Phenytoin-induced toxic epidermal necrol...

Which drug information source gives information regarding nutritional supplements? A. LactMed Database B. Natural Medicines Comprehensive Database C. United States Pharmacopeia (USP)/National Formulary (NF) D. USP Dictionary of United States Adopted Names (USAN) and International Drug Names - C. United States Pharmacopeia (USP)/National Formulary (NF) Which statement provides a definition of the trade name of a drug? A. The name under which the drug is listed in the US Pharmacopeia B. Th...

UNITEK HAYWARD Pharmacology Exam Questions With Verified And Updated Answers. Which description best defines a medication? A) Chemical substance that requires a prescription by a health professional B) Drug used for a therapeutic effect to treat or prevent an illness C) Pharmacologic preparation used to reverse disease D) Plant, animal, or mineral substance that prevents disease - answerB) Drug used for a therapeutic effect to treat or prevent an illness Medications are drugs used for t...

NU 578 Controlled Substances Quiz, Exam Questions With Complete Solution Updated 2024/2025 (100% Correct) Comprehensive Drug Abuse Prevention and Control Act - ANSWER Act also known as the Controlled Substance Act (1970) transmuscosal fentanyl only approved for breakthrough cancer pain in opioid tolerant patients - ANSWER actiq dopamine reward circuit - ANSWER addictive drugs all activate the brain's _________ naltrexone - ANSWER after detox, an opioid addict can be rx'd ___________ to ...

What is the waiting timeframe for a client taking acutane? - 6 months What is the waiting time for a client w/ autoimmune disease? - Doctor referral Tertiary colors are - Two secondary colors mixed (yellow-green, blue-green, blue-violet, red-violet, red-orange, yellow-orange) Secondary colors are - Two primary colors mixed (orange, green, violet) Primary colors are - red, yellow, blue Official Transcript - An original document authorized by the office (HECC), applicant identity informatio...

AANP Board Questions With Correct Answers 2023 INR values below ____ increase stroke risk sixfold. - CORRECT ANSWER-2 What allergy contradicts the use of thiazide diuretics? - CORRECT ANSWER-Sulfa Why should ACE-Is be avoided with renal stenosis? - CORRECT ANSWER-Leads to ARF Adverse effects of aldosterone antagonists (Aldactone) - CORRECT ANSWERGalactorrhea and hyperkalemia What are beta blocker indications? - CORRECT ANSWER-HTN, post-MI< angina, arrhythmias, migraine prophylaxis...

A nurse is preparing to give an oral dose of drug X to treat a patient's high blood pressure. After giving the drug, the nurse finds that it reduces the blood pressure without serious harmful effects, but it also causes the patient to have nausea and a headache. Based on this information, which property of an ideal drug is this drug lacking? a Effectiveness b Safety c Selectivity d Ease of administration C The drug is effective in lowering the blood pressure and safe in that it does not c...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

MPJE ILLINOIS VERIFIED ANSWERS Form to send to DEA for destroying controls DEA Form 41 Controlled substance theft/loss form? DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! How long to send in theft/loss form? 1 business day Do you need to report pseudophedrine as stolen? No, it is a C5 under state law but not controlled under federal law Difference between detox and maintenance treatment with methadone/LAAM Detox = <...

GMS6551 Review Exam Questions with 100% Verified Correct Answers which definition best describes a lead compound? the compound that is used for in vivo experiments the compound that is used for clinical trials the first compound discovered to have the desired activity the compound that is FDA approved - Correct Answer The first compound discovered to have the desired activity Which method of discovering a drug is generally the least expensive? natural products high-throughput screening...