37 Questions
What is the sponsor's responsibility that was NOT mentioned in the text?
Ensure proper disposal of investigational product
How long does the FDA have to file, or refuse to file, an NDA after receipt?
90 days
Which action would NOT be considered obstructing an inspection by the FDA?
Failing to schedule an inspection within 30 days
What is one of the responsibilities that the sponsor must fulfill according to the text?
Maintaining records of receipt, use and disposition of investigational product
If a sponsor fails to designate a qualified medical person, what could be the consequence?
FDA rejection of the NDA application
What would be a potential outcome if the FDA refuses to accept an NDA?
Requirement to restart the whole drug development process
Which scenario would be considered appropriate behavior during an FDA inspection?
Answering all questions truthfully and allowing access to records
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?
Full quality dossier
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?
Contact the regulatory authority that issued the request
What is the correct type of Variation to file when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
File a new Marketing Authorisation Application
Which of the following correctly describes an Authorized Generic Drug?
It is a copy of a brand-name drug that is developed independently
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?
14 days
What aspect of an Authorized Generic Drug distinguishes it from the brand-name drug?
Not being listed in the Orange Book
Which type of dossier should be included in the Marketing Authorisation Application for a follow-on biologic?
Quality dossier containing only comparative data
Which action would be inappropriate when handling a request from a regulatory authority?
Ignoring the request and taking no action
What is the regulatory action required when developing a follow-on biologic that is similar to an authorized biologic medicinal product?
File a new Marketing Authorisation Application
What should a company do before initiating product testing related to a regulatory request?
Verify the validity and authenticity of the request
If a follow-on biologic is being developed, what type of dossier should be included in the Marketing Authorisation Application?
Full quality dossier supplemented by comparability data
Why is it essential for a company to consult with a regulatory authority regarding product testing requirements?
To ensure alignment with regulations and avoid non-compliance
What is necessary to demonstrate when submitting a Marketing Authorisation Application for a follow-on biologic?
Comparability with existing products on the market
Which scenario best illustrates non-compliance with regulatory product testing requests?
A company conducts product testing without verifying the authenticity of the request
What was the primary issue faced by the company?
The company received a Warning Letter from the FDA regarding their marketed drug product.
What should be the top priority for the regulatory specialist to minimize legal liability?
Gather all relevant information for a risk assessment and seek preliminary legal advice.
How long has the company been marketing the drug in question?
Over 20 years
What type of adverse events were reported in relation to the company's drug?
Minor adverse events
What was the nature of the legal claim related to the company's product?
Claim from children whose mothers took a related product during pregnancy
What should the company's immediate response be regarding the press reports about the legal claim?
Gather more information before responding
What is the significance of the Warning Letter from the FDA?
It indicates a potential regulatory violation that requires immediate action.
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?
Signal
What is the correct term for a numerical rating that represents the strength of the relationship between an exposure and an outcome?
Index
What is a characteristic that can be objectively measured or quantified and represents the presence of disease or abnormality?
Sign
Which term refers to subjective evidence of disease or physical disturbance observed by the patient?
Symptom
In pharmacovigilance, what term describes unexpected, potentially causal relationships between drugs and adverse events?
Signal
Which term represents a measure or characteristic used to monitor or predict outcomes in pharmacovigilance?
Indicator
What is the term for a physical finding that is observed by someone other than the patient?
Sign
Which term defines a statistical concept used to measure the strength of association between variables?
Index
What is the term for an observation that raises concern about a possible drug-adverse event relationship requiring further investigation?
Indicator
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.
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.
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