Podcast
Questions and Answers
Which term in the context of RAC (Drugs) does not describe the same concept as the others?
Which term in the context of RAC (Drugs) does not describe the same concept as the others?
- Monoclonal antibody (correct)
- Follow-on protein products
- Biosimilars
- Subsequent entry biologics
According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs?
According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs?
- High systolic and diastolic blood pressures (correct)
- Formal mortality and morbidity outcomes
- Stroke and cardiovascular events
- Organ damage secondary to hypertension
What aspect of safety database for anti-hypertensive drugs includes 461 patients exposed for three months?
What aspect of safety database for anti-hypertensive drugs includes 461 patients exposed for three months?
- Medium-term exposure subset
- Short-term exposure subset (correct)
- Long-term exposure subset
- Intermediate-term exposure subset
In the safety database, what does a total exposure of 2.000 patients represent?
In the safety database, what does a total exposure of 2.000 patients represent?
Which factor is NOT typically considered in assessing the safety profile of an anti-hypertensive drug?
Which factor is NOT typically considered in assessing the safety profile of an anti-hypertensive drug?
What characteristic distinguishes monoclonal antibodies from biosimilars and follow-on protein products?
What characteristic distinguishes monoclonal antibodies from biosimilars and follow-on protein products?
Which exposure subset is most likely to provide insights into potential long-term safety issues of the anti-hypertensive drug?
Which exposure subset is most likely to provide insights into potential long-term safety issues of the anti-hypertensive drug?
What parameter is crucial for evaluating the effectiveness of antihypertensive drugs based on ICH guidelines?
What parameter is crucial for evaluating the effectiveness of antihypertensive drugs based on ICH guidelines?
Which of the following actions is considered a failure to allow an FDA investigator entry into a facility?
Which of the following actions is considered a failure to allow an FDA investigator entry into a facility?
What is the correct action that restarts the review clock for a Biologics License Application (BLA) that received a non-approval letter?
What is the correct action that restarts the review clock for a Biologics License Application (BLA) that received a 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?
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?
Which of the following actions by a facility is considered a failure to provide an FDA investigator with requested records?
Which of the following actions by a facility is considered a failure to provide an FDA investigator with requested records?
What type of supplement should a regulatory professional recommend for a change in the manufacturing process of a marketed drug product?
What type of supplement should a regulatory professional recommend for a change in the manufacturing process of a marketed drug product?
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?
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?
Which of the following actions by a facility is considered a failure to allow an FDA investigator entry during an unannounced inspection?
Which of the following actions by a facility is considered a failure to allow an FDA investigator entry during an unannounced inspection?
What type of supplement should a regulatory professional recommend for a change in the container closure system of a marketed drug product?
What type of supplement should a regulatory professional recommend for a change in the container closure system of a marketed drug product?
What is the correct strategy for extending a license to other EU member states?
What is the correct strategy for extending a license to other EU member states?
What is the legal status of European scientific guidelines?
What is the legal status of European scientific guidelines?
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?
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?
During which procedure should an applicant company representative be available to resolve any issues that may arise?
During which procedure should an applicant company representative be available to resolve any issues that may arise?
What is the purpose of the Mutual Recognition Procedure (MRP)?
What is the purpose of the Mutual Recognition Procedure (MRP)?
What is the Centralized Procedure with Prescription (CPP)?
What is the Centralized Procedure with Prescription (CPP)?
What is the purpose of the Decentralized Procedure (DCP)?
What is the purpose of the Decentralized Procedure (DCP)?
What is the role of the CEN (European Committee for Standardization) in relation to European scientific guidelines?
What is the role of the CEN (European Committee for Standardization) in relation to European scientific guidelines?
Which schedule would a drug with accepted medical use and limited potential for abuse be placed in?
Which schedule would a drug with accepted medical use and limited potential for abuse be placed in?
A drug with a high potential for abuse and no currently accepted medical use would likely be categorized as which schedule?
A drug with a high potential for abuse and no currently accepted medical use would likely be categorized as which schedule?
Which schedule is used for drugs with a moderate potential for abuse and currently accepted medical use?
Which schedule is used for drugs with a moderate potential for abuse and currently accepted medical use?
Drugs with a low potential for abuse and accepted medical uses are categorized under which schedule?
Drugs with a low potential for abuse and accepted medical uses are categorized under which schedule?
Which controlled substance schedule has the most restrictive policies and regulations?
Which controlled substance schedule has the most restrictive policies and regulations?
A pharmaceutical with a $\delta$-9-THC concentration greater than 0.3% would likely be placed in which schedule?
A pharmaceutical with a $\delta$-9-THC concentration greater than 0.3% would likely be placed in which schedule?
Which schedule covers drugs with currently accepted medical uses and a low potential for abuse?
Which schedule covers drugs with currently accepted medical uses and a low potential for abuse?
Drugs containing narcotics like codeine or opium would likely fall under which controlled substance schedule?
Drugs containing narcotics like codeine or opium would likely fall under which controlled substance schedule?
What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?
What is the most appropriate next regulatory step after a clinical trial for a medicinal product has been finalized in several European countries?
According to ICH Q10, which of the following is NOT addressed by implementing a Pharmaceutical Quality System (PQS)?
According to ICH Q10, which of the following is NOT addressed by implementing a Pharmaceutical Quality System (PQS)?
Which changes are parallel distributors allowed to introduce to the packaging of a centrally authorised medicinal product?
Which changes are parallel distributors allowed to introduce to the packaging of a centrally authorised medicinal product?
A variation for a complex manufacturing change should include which of the following?
A variation for a complex manufacturing change should include which of the following?
What is the correct acronym for the 'Medical Dictionary for Regulatory Activities'?
What is the correct acronym for the 'Medical Dictionary for Regulatory Activities'?
Which of the following is NOT a component of the WHO Adverse Reactions Terminology?
Which of the following is NOT a component of the WHO Adverse Reactions Terminology?
What is the purpose of the MedDRA terminology?
What is the purpose of the MedDRA terminology?
Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) according to ICH Q10?
Which of the following is NOT a benefit of implementing a Pharmaceutical Quality System (PQS) according to ICH Q10?
