RAC (Drugs) Practice Test: Conducting Testing and Submission Process

Conduct testing and submit the change as an amendment = Obtain approval for submission and submit the change in the next annual report Take no action and leave the submission as is = Obtain approval for submission and submit the change in the next annual report Petition the FDA for a stay of action and reconsider = Obtain approval for submission and submit the change in the next annual report Obtain approval for submission and submit the change in the next annual report = Conduct testing and submit the change as an amendment

A Request for Determination to the appropriate review division based on the product’s primary mode of action = A Request for Designation to the Office of New A Request for Designation to the Office of New = A Request for Designation to the Office of Combination Products A Request for Determination to the Office of Pharmacovigilance = A Request for Designation to the Office of Combination Products

Conduct testing and submit the change as an amendment = Submit the validation protocol for review prior to execution of the study Take no action and leave the submission as is = Submit the validation protocol for review prior to execution of the study Petition the FDA for a stay of action and reconsider = Submit the validation protocol for review prior to execution of the study Obtain approval for submission and submit the change in the next annual report = Submit the validation protocol for review prior to execution of the study

<p>Publication copyright statements = Approval from the ethics committee Signed informed consent forms = Approval from the ethics committee Appropriate ICH forms = Approval from the ethics committee Approval from the ethics committee = Approval from the ethics committee</p> Signup and view all the answers

<p>The content and format of the SmPC = The opportunity to obtain an SPC The possibility to obtain protection from gener = The opportunity to obtain an SPC The opportunity to obtain an SPC = The opportunity to obtain an SPC The process for filing a European patent applic = The opportunity to obtain an SPC</p> Signup and view all the answers

<p>After study commencement, the MAH must submit an = All of the above. Final Assessment by Pharmacovigilance Risk Asses = All of the above. Upon study completion, a final study report with = All of the above. All of the above. = All of the above.</p> Signup and view all the answers

<p>Publication copyright statements = No match Approval from the ethics committee = No match Appropriate ICH forms = No match Signed informed consent forms = No match</p> Signup and view all the answers

<p>Recommendation: Be extended to other batches of Drug Product = Action: Further production should be halted until the reason for the discrepancy is identified Recommendation: Be extended to other drug products that may have been associated with the discrepancy = Action: Correct answer Recommendation: No immediate action is needed but the discrepancy should be monitored = Action: Further investigation required Recommendation: Immediate halt of all production activities = Action: Investigate the root cause before resuming production</p> Signup and view all the answers

<p>Retention Period: Until the batch expiration date = Records: Production, labeling, and packaging records Retention Period: One year after the batch expiration date = Records: All production, labeling, and packaging records Retention Period: Three years after the batch expiration date = Records: Batch-specific manufacturing records only Retention Period: Five years after the last distribution date for the batch = Records: Distribution and sales reports only</p> Signup and view all the answers

<p>Scenario: A clinical investigator seeks to treat a critically ill patient not meeting protocol criteria = Action: Proceed with compassionate use protocols Scenario: A clinical investigator wants to use an unapproved drug for a non-serious condition in a clinical trial = Action: Seek approval from regulatory authorities before proceeding Scenario: A patient enrolled in a trial experiences severe adverse reactions to an investigational drug = Action: Report immediately to regulatory bodies and suspend further dosing Scenario: A drug manufacturer discovers a defect in packaging post-distribution = Action: Initiate a product recall and investigate potential impact on patient safety</p> Signup and view all the answers

<p>Book a meeting with health authority = Initiate the meeting scheduling process Compile the documents required for meeting = Gather necessary paperwork for submission Check with internal stakeholders on the readiness = Ensure all required documents are prepared Check on the list of attendees for the meeting = Verify who will be present at the meeting</p> Signup and view all the answers

<p>OPDP will consider whether the promotional material = Review the content of promotional materials OPDP will consider the REMS and boxed warnings = Evaluate safety information in promotions OPDP will consider whether the promotional claim = Assess the accuracy of marketing statements OPDP will take no action as their role is purely advisory = Provide guidance without enforcement powers</p> Signup and view all the answers

<p>Book a meeting with health authority = Schedule an appointment with regulatory officials Compile the documents required for meeting = Organize essential paperwork for submission Check with internal stakeholders on the readiness = Ensure all stakeholders are prepared for submission Check on the list of attendees for the meeting = Confirm who will be participating in the meeting</p> Signup and view all the answers

<p>Gather all pertinent information for a risk-assessment = Top priority for a regulatory specialist Respond to the FDA WL immediately = Immediate action after receiving a Warning Letter Gather all pertinent information and use your 25 = Action not recommended to minimize legal liability Respond without delay to the press reports denying = Inappropriate response to press reports</p> Signup and view all the answers

<p>Warning Letter from the FDA regarding adulterated drug = Linked to hundreds of reports of minor AEs Related product reported in press involving legal claim by children = Mothers took medication during pregnancy many years ago Successfully marketed drug for over 20 years without incident = Unexpected legal challenges arise Legal liability concerns for the company = Regulatory specialist's top priority</p> Signup and view all the answers

<p>Risk-assessment = Process of evaluating potential risks FDA WL = Warning Letter issued by the FDA Press reports denying = Response to media allegations Antihypertensive drugs' efficacy assessment basis according to ICH = Primary assessment criterion</p> Signup and view all the answers

<p>Gather all pertinent information for a risk-assessment and recommend obtaining preliminary legal advice.</p> Signup and view all the answers

<p>Ingredient adulteration</p> Signup and view all the answers

<p>Blood pressure reduction</p> Signup and view all the answers

<p>Seek legal advice and assess risk.</p> Signup and view all the answers

<p>Consult with legal experts and assess risks.</p> Signup and view all the answers

<p>Gather information for risk assessment and seek legal advice.</p> Signup and view all the answers

<p>Consult with legal experts before responding.</p> Signup and view all the answers

<p>Gather information, assess risks, and seek legal advice.</p> Signup and view all the answers

<p>Obtain approval from the CA for compassionate use of the product for this particular patient</p> Signup and view all the answers

<p>Treat this particular patient with the product</p> Signup and view all the answers

<p>Request feedback from the Committee for Medicinal Products for Human Use (CHMP)</p> Signup and view all the answers

<p>Details about patient enrollment criteria</p> Signup and view all the answers

<p>Packaging and labeling specifications</p> Signup and view all the answers

<p>Ignoring feedback from stakeholders</p> Signup and view all the answers

<p>Following local regulations and ethical considerations</p> Signup and view all the answers

<p>Ensuring equitable access to treatment</p> Signup and view all the answers

<p>100 patients for 12 months</p> Signup and view all the answers

<p>Investigational drugs with or without an IND</p> Signup and view all the answers

<p>Investigator's brochure (IB)</p> Signup and view all the answers

<p>The question does not provide enough information</p> Signup and view all the answers

<p>100 patients</p> Signup and view all the answers

<p>Maryland, USA</p> Signup and view all the answers

<p>12 months</p> Signup and view all the answers

<p>Study protocol</p> Signup and view all the answers

<p>Specifying the sites in the EU where the product will be used</p> Signup and view all the answers

<p>Conduct bioavailability and bioequivalence studies only</p> Signup and view all the answers

<p>'Keep out of reach of children' statement</p> Signup and view all the answers

<p>Including bioavailability and bioequivalence studies information</p> Signup and view all the answers

<p>Performing bioavailability and bioequivalence studies</p> Signup and view all the answers

<p>'For EU sites' labeling specification</p> Signup and view all the answers

<p>'Period of use for product' specification</p> Signup and view all the answers

<p>'For sites in the EU' labeling requirement</p> Signup and view all the answers

<p>To discuss and establish common guidelines for safe, effective, and high-quality medicines</p> Signup and view all the answers

<p>European Medicines Agency (EMA)</p> Signup and view all the answers

<p>The monitor reviews the deviation against the trial monitoring plan and takes corrective action</p> Signup and view all the answers

<p>The investigator should be provided additional training on protocol adherence</p> Signup and view all the answers

<p>Reduction in both systolic and diastolic blood pressure</p> Signup and view all the answers

<p>Minimizing the company's legal exposure and avoiding further liability</p> Signup and view all the answers

<p>Drugs approved for marketing or clinical trials in the USA</p> Signup and view all the answers

<p>The potential for adverse events in the patient</p> Signup and view all the answers