RAC Exam practice Questions & Answers 2023 Review Update, US RAC Review Questions RAPS Modules Questions & Answers, RAC Exam Prep - EU MDD-AIMDD & MDR, RAC Pharmaceuticals Questions & Answers 2023 A+

A patient brings a prescription for hydrocodone/APAP (Vicodin) #60 tablets with five refills. The patient can only pay for 30 tablets this week. How many refills are available to be filled in the next 6 months after this one to include the extra 30 tablets that have not been picked up? - ANS-5 ...

RAC Preparation Questions & Answers The two mechanisms to amend an OTC Monograph are: - Answer-TEA or Citizen Petition, is correct. A company is planning to implement a few minor manufacturing changes for its FDA-approved device. The company currently is conducting a clinical study for a new ind...

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and s...

RAC Practice Exam 2 -HJ Questions & Answers You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for fu...

RAC Pharmaceuticals Questions & Answers 2023 A+ When would you have a type A meeting? - Correct Ans-dispute resolution, Clinical Holds, Special Protocol Assignment, Post Action Meeting (held within 30 days, with FDA response in 14 to schedule, briefing materials are need at least two weeks befo...

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 ma...

RAC Exam Prep 2023 International Regulatory Qs&As Members of IMDRF - ANS-Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, S. Korea, US What types of evaluations are typical variable from nation to nation? - ANS-Performance and clinical evaluations What is the Helsinki Declara...

2023 US RAC Practice Exam Questions With Correct Explanations A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to...

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 su...

RAC DRUGS Questions And Answers (EU) MA - Answer-Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - Answer-National, centralised, mutual recognition, decentralized procedures MAH - Answer-A legal p...

Device RAC Exam Questions & Answers With Accurate Explanations 2023 Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANS-C. CDRH In this combination of a device and a drug, the primary mode of ...

RAC Device Quiz & Answers Correct Review Solution EU: Which of the following does NOT describe the CE Mark or its use? A)The CE Mark is an external indication that a device meets the Essential Requirements B)The manufacturer and/or the Notified Body have checked the device against specifications ...

RAC Devices Exam Prep 2023 (EU) Qs&As Who is the European Medicines Agency (EMA) - ANSWER-an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regu...

RAC Exam Prep - EU MDD-AIMDD & MDR Similar but more detailed than the Essential Requirements - ANS-General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ANS-13485:2016 Which entity affixe...