Fda reporting - Study guides, Class notes & Summaries

NUR 641E Final Exam 2023 | Advanced for the Nurse Educator with Complete Solutions Pharmacokinetics involves absorption, distribution, metabolism and elimination). Absorption: absorption from the administration site either directly or indirectly into the blood/plasma. Distribution: reversibly or irreversibly move from the bloodstream into the interstitial and intracellular Metabolism: biotransformed via hepatic metabolism or by other tissues. Elimination: tissues. lastly, the drug an...

NURS 615 EXAM 3 QUESTIONS AND ANSWERS Chapter 25. Drugs Used in Treating Inflammatory Processes 1. Henry presents to clinic with a significantly swollen, painful great toe and is diagnosed with gout. Of the following, which would be the best treatment for Henry? 1. High-dose colchicine 2. Low-dose colchicine 3. High-dose aspirin 4. Acetaminophen with codeine 2. Patient education when prescribing colchicine includes: 1. Colchicine may be constipating. 2. Colchicine always causes so...

RAC Practice Exam 2009 Questions and Answers All Correct A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from the FDA, what is the earliest that clinical studies can be initiated? A. The sponsor must wait for FDA approval. B. Upon IRB approval from any study center. C. 30 days from receipt by FDA. D. 90 days from receipt by FDA. - Answer- C. 30 days from receipt by FDA. The IDE/IND goes into effect 30 days after receipt by FDA...

CPPS Patient Safety Certification Questions ready for exams with 100% pass 2023advance health One important route to restoring trust is through a commitment to transparency by all health care systems. Organizations and clinicians that act as though they have nothing to hide become more trustworthy. The health care system should seek to earn renewed trust not by hiding its defects, but by revealing them, along with making a relentless commitment to improve. The transition to openness is a diffic...

Form to send to DEA for destroying controls - correct answer DEA Form 41 Controlled substance theft/loss form? - correct answer 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? - correct answer 1 business day Do you need to report pseudophedrine as stolen? - correct answer No, it is a C5 under state law but not controlled under federal law Difference between detox and maintenance treatmen...

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

Final Exam: NURS 6540/ NURS6540 Test Bank | Advanced Practice Care of Frail Elders| More than 200 Questions and Answers with Rationales | Complete Guide| Verified 2023/2024 1. Mrs. Keating is a 70-year-old woman suffering from arthritis. She is seeing the nurse practitioner for her regular checkup. For a person with chronic degenerative conditions, which of the following should the nurse suggest for health promotion? 1. Take herbal supplements. 2. Increase physical activity. 3. Take ...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

PTCB Immunization Certificate, questions and answers 100% correct storage and handling plans include: 1. ordering and accepting vaccine deliveries 2. storing and handling vaccines 3. managing inventory 4. managing potentially compromised vaccines 5. backup plans for power outages. equipment malfunctions and disasters 6. packing materials CDC SOP recommendations 1. staff training and continuing education 2. routine storage and handling 3. emergency vaccine storage, handling and t...

PTCB EXAM TEST BANK QUESTIONS AND ANSWERS LATEST WITH RATIONALE Multiple choice What is the route of administration for a prescription with the following directions: "i supp pr q 6 hr prn"? A. Orally B. Rectally C. Urethrally D. Vaginall {{Correct Ans- B. Rectally Rationale: "pr" means per rectum. What is the meaning of PDA? A. Personal digital aid B. Personal digital assistant C. Physician digital assistant D. Pharmaceutical data assistant {{Correct Ans- B. Personal dig...