Regulatory Affairs & Quality Assurance PYQs – Set 171
Subject : Regulatory Affairs & Quality Assurance
3401. The requirement and guidelines for contract research comes in which Schedule
Regulatory Affairs & Quality Assurance • • NIPER 2018
3402. The term WIPO stands for
Regulatory Affairs & Quality Assurance • • NIPER 2018
3403. Orphan drugs are
Regulatory Affairs & Quality Assurance • • NIPER 2018
3404. The maximum number of drugs approved by USFDA in last five years are –––––– in nature
Regulatory Affairs & Quality Assurance • • NIPER 2018
3405. As per DPCO 2013, what is the method of drug pricing
Regulatory Affairs & Quality Assurance • • NIPER 2018
3406. New Drug Application is done
Regulatory Affairs & Quality Assurance • • NIPER 2018
3407. Consumer protection in India is ensured by
Regulatory Affairs & Quality Assurance • • NIPER 2018
3408. For a generic drug to be bioequivalent to an innovator drug (per FDA), it must be measured in ––––––– of subjects to fall within _____ of the mean of the test population bioavailability
Regulatory Affairs & Quality Assurance • • NIPER 2018
3409. Adverse Drug Experience as Defined by Regulation (21 CFR 314.80) are reported to Division of
Regulatory Affairs & Quality Assurance • • NIPER 2018
3410. DPCO is implemented by
Regulatory Affairs & Quality Assurance • • NIPER 2018
3411. The first EMR (exclusive marketing right) was granted in India that created controversy was to
Regulatory Affairs & Quality Assurance • • NIPER 2018
3412. To ensure availability of the medicines at appropriate prices, DPCO was introduced in
Regulatory Affairs & Quality Assurance • • NIPER 2018
3413. A regulatory body of Japan is
Regulatory Affairs & Quality Assurance • • NIPER 2018
3414. which of the following is not true for a patent
Regulatory Affairs & Quality Assurance • • NIPER 2018
3415. Who is the current DCGI
Regulatory Affairs & Quality Assurance • • NIPER 2018
3416. Recently ranitidine, metformin were in news due to presence of which impurity?
Regulatory Affairs & Quality Assurance • • NIPER 2018
3417. Original X company sells its product under the name 'Phido'. Company Y begins to market an identical product under the name 'Fido'. This is case of
Regulatory Affairs & Quality Assurance • • NIPER 2018
3418. Assessment, control, communication and review of risks to the quality of the drug product across the product life cycle is
Regulatory Affairs & Quality Assurance • • NIPER 2018
3419. QbD is described in ICH guidelines
Regulatory Affairs & Quality Assurance • • NIPER 2018
3420. Medical devices are notified as DRUGS under Drugs & Cosmetics Act. Schedule for Medical devices GMP requirements are specified under
Regulatory Affairs & Quality Assurance • • NIPER 2018
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