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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 - Answer-C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is ...

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Answer-C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fun...

First course of action to market a new class III medical device technology in the shortest time is... - Answer- to collect required clinical data Instructions for Use language is defined by the Member State. Having a local distributor is not a mandatory requirement. - Answer- Transposed Meidcal D...

Technicians may help prevent medication errors by - Answer- keeping their work areas free of clutter Medication error prevention best practices in the pharmacy include - Answer- all of the above A prescriber writes a prescription for gentamicin (Garamycin) eyedrops to be used 2 GTTS OS BID. Th...

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...

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 ...

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: - Answer-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescript...

(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 person or legal entity who must be ...

Regulations - Answer-interpret laws and describe how they will be enforced guidance document - Answer-used to convey FDA's current thinking or enforcement priorities - not legally binding Sherley Amendment - Answer-prohibited labeling medicines with false therapeutic claims intended to defraud...

RAC Exam Practice Questions with Complete Answers 2023

RAC Exam Questions - NJ Edits- Correct Answers provided- Latest Update 2023

RAC Exam Questions with Complete Solutions Latest (Graded A+)

RAC Pharmaceuticals Exam Questions with Complete Solutions 2023

RAC Pharmaceuticals Exam Questions with Complete Solutions 2023