40 Questions
Which term in the context of RAC (Drugs) does not describe the same concept as the others?
Monoclonal antibody
According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs?
High systolic and diastolic blood pressures
What aspect of safety database for anti-hypertensive drugs includes 461 patients exposed for three months?
Short-term exposure subset
In the safety database, what does a total exposure of 2.000 patients represent?
Cumulative exposure count
Which factor is NOT typically considered in assessing the safety profile of an anti-hypertensive drug?
Geographical distribution of patients
What characteristic distinguishes monoclonal antibodies from biosimilars and follow-on protein products?
Origin from recombinant DNA technology
Which exposure subset is most likely to provide insights into potential long-term safety issues of the anti-hypertensive drug?
74 patients exposed for 12 months
What parameter is crucial for evaluating the effectiveness of antihypertensive drugs based on ICH guidelines?
$\text{High systolic and diastolic blood pressures}$
Which of the following actions is considered a failure to allow an FDA investigator entry into a facility?
Certain staff members being unavailable during an unannounced inspection
What is the correct action that restarts the review clock for a Biologics License Application (BLA) that received a non-approval letter?
Submitting a complete response to the non-approval letter
If a supplier discontinues production of a resin used in a marketed drug product's container, what mechanism should a regulatory professional recommend to maintain compliance?
Submit a Prior Approval Supplement
Which of the following actions by a facility is considered a failure to provide an FDA investigator with requested records?
Providing incomplete records without explanation
What type of supplement should a regulatory professional recommend for a change in the manufacturing process of a marketed drug product?
Prior Approval Supplement
If a regulatory professional submits a complete response to a non-approval letter for a Biologics License Application (BLA), what happens to the review clock?
The review clock is restarted from the date of the complete response submission
Which of the following actions by a facility is considered a failure to allow an FDA investigator entry during an unannounced inspection?
Delaying the investigator's entry by a few hours without explanation
What type of supplement should a regulatory professional recommend for a change in the container closure system of a marketed drug product?
Prior Approval Supplement
What is the correct strategy for extending a license to other EU member states?
Use the Mutual Recognition Procedure (MRP)
What is the legal status of European scientific guidelines?
They have no legal force but are highly recommended
How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant?
120 days
During which procedure should an applicant company representative be available to resolve any issues that may arise?
Both MRP and DCP
What is the purpose of the Mutual Recognition Procedure (MRP)?
To extend an existing marketing authorization to other EU member states
What is the Centralized Procedure with Prescription (CPP)?
A procedure for obtaining marketing authorization in all EU member states simultaneously
What is the purpose of the Decentralized Procedure (DCP)?
To obtain initial marketing authorization in one EU member state
What is the role of the CEN (European Committee for Standardization) in relation to European scientific guidelines?
The CEN has no direct role in relation to European scientific guidelines
Which schedule would a drug with accepted medical use and limited potential for abuse be placed in?
Schedule IV
A drug with a high potential for abuse and no currently accepted medical use would likely be categorized as which schedule?
Schedule I
Which schedule is used for drugs with a moderate potential for abuse and currently accepted medical use?
Schedule III
Drugs with a low potential for abuse and accepted medical uses are categorized under which schedule?
Schedule V
Which controlled substance schedule has the most restrictive policies and regulations?
Schedule I
A pharmaceutical with a $\delta$-9-THC concentration greater than 0.3% would likely be placed in which schedule?
Schedule I
Which schedule covers drugs with currently accepted medical uses and a low potential for abuse?
Schedule V
Drugs containing narcotics like codeine or opium would likely fall under which controlled substance schedule?
Schedule II
What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?
File a declaration on the end of the clinical trial to the competent authorities and ethics committees of the participating countries
According to ICH Q10, which of the following is NOT addressed by implementing a Pharmaceutical Quality System (PQS)?
A PQS can be certified through the ICH Q10 Certification Programme
Which changes are parallel distributors allowed to introduce to the packaging of a centrally authorised medicinal product?
Use of different language versions of labelling and package leaflet
A variation for a complex manufacturing change should include which of the following?
All of the above
What is the correct acronym for the 'Medical Dictionary for Regulatory Activities'?
MedDRA
Which of the following is NOT a component of the WHO Adverse Reactions Terminology?
None of the above
What is the purpose of the MedDRA terminology?
To standardize the coding of adverse event information in clinical trials
Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) according to ICH Q10?
Reducing the frequency of regulatory inspections
Test your knowledge on FDA inspection violations by identifying scenarios such as failing to produce requested records in a timely manner or denying entry to investigators for unannounced inspection. Learn about common violations in facility inspections.
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