RAC EXAM PACKAGE DEAL WITH COMPLETE SOLUTIONS.

drug - An article intended for use in the diagnosis, cure mitigation treatment or prevention of disease in man new drug - -New use of a drug substance or component (active ingredient, excipient, carrier, coating). -New use of a combination of approved drugs -Change in proportion of ingredients ...

(EU) MA - 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 - National, centralised, mutual recognition, decentralized procedures MAH - A legal person or legal entity who must be established in the Euro...

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in proc...

Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - Answer-A: Proof of efficacy Which amendments to the FD&C Act ...

ANDA - Abbreviated New Drug Application BLA - Biologics License Application CA - Competent Authority CBE - Changes Being Effected CEN - European Committee for Standardization CPP - Certificate of a Pharmaceutical Product CTD - Common Technical Document CV - Curriculum Vitae DCP - Decentralis...

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...

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

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to lo...

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of s...

(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 es...