Podcast
Questions and Answers
What is the sponsor's responsibility that was NOT mentioned in the text?
What is the sponsor's responsibility that was NOT mentioned in the text?
- Designate appropriately qualified medical person
- Ensure proper disposal of investigational product (correct)
- Submitting unanticipated adverse event reports
- Update the Investigators Brochure as significant
How long does the FDA have to file, or refuse to file, an NDA after receipt?
How long does the FDA have to file, or refuse to file, an NDA after receipt?
- 120 days
- 30 days
- 45 days
- 90 days (correct)
Which action would NOT be considered obstructing an inspection by the FDA?
Which action would NOT be considered obstructing an inspection by the FDA?
- Failing to schedule an inspection within 30 days (correct)
- Allowing an investigator to enter but refusing to provide documents
- A facility not providing an FDA investigator access to records
- Scheduling an inspection at a date later than requested
What is one of the responsibilities that the sponsor must fulfill according to the text?
What is one of the responsibilities that the sponsor must fulfill according to the text?
If a sponsor fails to designate a qualified medical person, what could be the consequence?
If a sponsor fails to designate a qualified medical person, what could be the consequence?
What would be a potential outcome if the FDA refuses to accept an NDA?
What would be a potential outcome if the FDA refuses to accept an NDA?
Which scenario would be considered appropriate behavior during an FDA inspection?
Which scenario would be considered appropriate behavior during an FDA inspection?
What should a regulatory professional submit with a Marketing Authorisation Application dossier for a follow-on biologic that is similar to an authorized biologic medicinal product already on the market?
What should a regulatory professional submit with a Marketing Authorisation Application dossier for a follow-on biologic that is similar to an authorized biologic medicinal product already on the market?
What should a company do FIRST when receiving a request from a regulatory authority to conduct product testing in compliance with a newly issued regulation?
What should a company do FIRST when receiving a request from a regulatory authority to conduct product testing in compliance with a newly issued regulation?
What is the correct type of Variation to file when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
What is the correct type of Variation to file when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
Which of the following correctly describes an Authorized Generic Drug?
Which of the following correctly describes an Authorized Generic Drug?
How many days does the reference member state have, after the start of the DCP Assessment Step I, to supply the draft labeling to concerned member states and the applicant?
How many days does the reference member state have, after the start of the DCP Assessment Step I, to supply the draft labeling to concerned member states and the applicant?
What aspect of an Authorized Generic Drug distinguishes it from the brand-name drug?
What aspect of an Authorized Generic Drug distinguishes it from the brand-name drug?
Which type of dossier should be included in the Marketing Authorisation Application for a follow-on biologic?
Which type of dossier should be included in the Marketing Authorisation Application for a follow-on biologic?
Which action would be inappropriate when handling a request from a regulatory authority?
Which action would be inappropriate when handling a request from a regulatory authority?
What is the regulatory action required when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
What is the regulatory action required when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
What should a company do before initiating product testing related to a regulatory request?
What should a company do before initiating product testing related to a regulatory request?
If a follow-on biologic is being developed, what type of dossier should be included in the Marketing Authorisation Application?
If a follow-on biologic is being developed, what type of dossier should be included in the Marketing Authorisation Application?
Why is it essential for a company to consult with a regulatory authority regarding product testing requirements?
Why is it essential for a company to consult with a regulatory authority regarding product testing requirements?
What is necessary to demonstrate when submitting a Marketing Authorisation Application for a follow-on biologic?
What is necessary to demonstrate when submitting a Marketing Authorisation Application for a follow-on biologic?
Which scenario best illustrates non-compliance with regulatory product testing requests?
Which scenario best illustrates non-compliance with regulatory product testing requests?
What was the primary issue faced by the company?
What was the primary issue faced by the company?
What should be the top priority for the regulatory specialist to minimize legal liability?
What should be the top priority for the regulatory specialist to minimize legal liability?
How long has the company been marketing the drug in question?
How long has the company been marketing the drug in question?
What type of adverse events were reported in relation to the company's drug?
What type of adverse events were reported in relation to the company's drug?
What was the nature of the legal claim related to the company's product?
What was the nature of the legal claim related to the company's product?
What should the company's immediate response be regarding the press reports about the legal claim?
What should the company's immediate response be regarding the press reports about the legal claim?
What is the significance of the Warning Letter from the FDA?
What is the significance of the Warning Letter from the FDA?
Which term is defined as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously?
Which term is defined as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously?
What is the correct term for a numerical rating that represents the strength of the relationship between an exposure and an outcome?
What is the correct term for a numerical rating that represents the strength of the relationship between an exposure and an outcome?
What is a characteristic that can be objectively measured or quantified and represents the presence of disease or abnormality?
What is a characteristic that can be objectively measured or quantified and represents the presence of disease or abnormality?
Which term refers to subjective evidence of disease or physical disturbance observed by the patient?
Which term refers to subjective evidence of disease or physical disturbance observed by the patient?
In pharmacovigilance, what term describes unexpected, potentially causal relationships between drugs and adverse events?
In pharmacovigilance, what term describes unexpected, potentially causal relationships between drugs and adverse events?
Which term represents a measure or characteristic used to monitor or predict outcomes in pharmacovigilance?
Which term represents a measure or characteristic used to monitor or predict outcomes in pharmacovigilance?
What is the term for a physical finding that is observed by someone other than the patient?
What is the term for a physical finding that is observed by someone other than the patient?
Which term defines a statistical concept used to measure the strength of association between variables?
Which term defines a statistical concept used to measure the strength of association between variables?
What is the term for an observation that raises concern about a possible drug-adverse event relationship requiring further investigation?
What is the term for an observation that raises concern about a possible drug-adverse event relationship requiring further investigation?
Flashcards
Sponsor's Responsibility (Records)
Sponsor's Responsibility (Records)
Sponsors are not responsible for maintaining records of investigational product receipt, use, and disposal.
Sponsor's Responsibility (Medical)
Sponsor's Responsibility (Medical)
Sponsors must designate a qualified medical professional and report unanticipated adverse events.
Sponsor's Responsibility (Brochure)
Sponsor's Responsibility (Brochure)
Sponsors must update the Investigator's Brochure with new information.
NDA Filing Timeframe
NDA Filing Timeframe
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Obstructing an FDA Inspection
Obstructing an FDA Inspection
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FDA Inspection (Refusal)
FDA Inspection (Refusal)
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Follow-on Biologic Dossier
Follow-on Biologic Dossier
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DCP Assessment Timeline
DCP Assessment Timeline
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Product Testing Request
Product Testing Request
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Authorized Generic Drug (Listing)
Authorized Generic Drug (Listing)
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Authorized Generic Drug (Origin)
Authorized Generic Drug (Origin)
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Authorized Generic Drug (Equivalence)
Authorized Generic Drug (Equivalence)
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Warning Letter Response
Warning Letter Response
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Adverse Event Signal
Adverse Event Signal
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Study Notes
Sponsor's Responsibility
- The sponsor is not responsible for maintaining records of receipt, use, and disposition of investigational product.
- The sponsor is responsible for designating an appropriately qualified medical person and submitting unanticipated adverse event reports.
- The sponsor is also responsible for updating the Investigators Brochure as significant new information becomes available.
NDA Filing
- The FDA must file or refuse to file an NDA within 60 days after receipt.
FDA Inspection
- The FDA considers a facility's failure to produce requested records in a timely manner, without a reasonable explanation, as obstructing an inspection.
- A facility's refusal to allow an investigator to enter the site or scheduling an inspection at a later date are not considered obstructing an inspection.
Marketing Authorisation Application
- A full quality dossier supplemented by the demonstration of comparability is required for a biotechnology company developing a follow-on biologic.
DCP Assessment
- The reference member state has 6 days to supply the draft labeling to the concerned member states and applicant after the start of the DCP Assessment Step I.
Product Testing
- When receiving a request from a regulatory authority to conduct product testing in compliance with a newly issued regulation, the company should first contact the regulatory authority to discuss the requirement.
Authorized Generic Drug
- An authorized generic drug is not listed in the Orange Book.
- It is a copy of a brand-name drug that is developed and approved by the brand-name manufacturer.
- It is the same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling.
Warning Letter
- When receiving a Warning Letter from the FDA, the top priority is to gather all pertinent information for a risk-assessment and recommend to the Senior Leadership Team that preliminary legal advice is obtained without delay.
Adverse Event
- A signal is reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.
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Description
Test your knowledge of Regulatory Affairs Certification (RAC) related to Drugs with US Based Questions from Pool 01. This practice test covers topics from Domain I and II, including understanding the sponsor’s responsibilities.
