RAC Questions And Answers 2023

When is an NDA annual report due? - ANS-60 days after the anniversary date of U.S. approval of the application. NDA Reporting Period ? All Blood and HCT/P Problems - ANS-45 calendar days of Fatal/Life threateneing/Disabling/Surgical Intervention and hospitalization Reporting Period? Postmarket Device Death, Serious Injury, Malfunction - ANS-Within 30 calendar days of awareness Reporting Period? Device Special FDA, or Remedial Action to Prevent Death/Harm - ANS-Within 5 work days of awareness Device Post market Reports of deaths and serious injuries by importer - ANS-Within 30 calendar days of awareness Device Post Market Reports of malfunctions - importer - ANS-Within 30 calendar days of awareness Reporting Period? Device-related Death - user facility - ANS-Within 10 work days of becoming aware Reporting Period? Device serious industry - user facility - ANS-Within 10 work days of becoming aware When do you submit the Device Annual Summary, User Facility - ANS-January 1 for the preceding year Reporting Period? Device Unanticipated Adverse Event on IDE - ANS-Within 10 work days of becoming aware Type A Meeting Types - ANS-Dispute Resolution After product approval, ADEs that do not meet the 15-day reporting requirements should be reported by the company: - ANS-Quarterly for three years after application approval, annually thereafter, unless alternative reporting is required by FDA. An Investigational New Drug Application (IND) goes to the "Inactive Status" when: - ANS-No subjects are entered into clinical trials for a period of two years or the IND is on clinical hold for one year. Which of the following is the best regulatory pathway for drugs containing similar active ingredients as a previously approved drug for a new indication - ANS-505(b)(2) NDA A company is developing a new device and the classification under which it would fall is unclear. As the regulatory professional, you would submit the following: - ANS-513(g) Request for Information How many days does FDA have to review an Abbreviated 510(k)? - ANS-90 days How many days does FDA have to review an Special 510(k)? - ANS-30 days Your company is making a change to a specification to comply with an official compendium of an NDA product. How should this change be reported? - ANS-As an update in the next Annual Report The drug substance manufacturing plant proposes widening a critical in-process test limit associated with the final intermediate manufacturing process. What will need to be done for the plant to implement the change? - ANS-File a Prior Approval Supplement and wait for agency approval before implementation A pharmaceutical company received approval of a drug that contains a boxed warning on its labeling. What type(s) of advertisements are NOT permitted? - ANS-Reminder advertisements A company decides to add an additional quality control test during in-process testing of its marketed Class III device. The appropriate submission to send to FDA for this change is: - ANS-Special PMA Supplement—Changes Being Effected What type of communication will FDA send an applicant when the review division concludes an NDA or ANDA cannot be approved in its present form and certain additional information or clarifications are needed? - ANS-Complete response letter A company has a new oral drug, GOODDRUG, it wishes to market in the US. Studies on intravenous GOODDRUG have been conducted by several academic centers demonstrating safety and efficacy and have been published in peer-reviewed journals. The most-appropriate method to gain approval would be by filing a: - ANS-505(b)2 Which FDA expedited program for serious conditions allows approval without demonstration of efficacy. - ANS-Accelerated Approval Company X is planning to conduct a clinical investigation for its new oral suspension for a reconstituted drug product. What information related to expiration dating is Company X required to include in the investigational drug product labeling? - ANS-Reconstituted drug product expiration information is required Company X has conducted clinical studies to support drug A's safety and effectiveness. Company X is planning to develop a new drug A dosage formulation and route of administration. This new formulation will rely on previously conducted clinical studies to support drug A's safety and effectiveness. Which of the following should be submitted by Company X? - ANS-An NDA containing full reports of investigations of safety and effectiveness FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, first-reviewed" review order for original Abbreviated New Drug Applications (ANDAs), amendments and supplements unless there is specific reason to expedite an application. Which of the following is NOT specific reason to grant expedited review? - ANS-Products that show evidence of safety and effectiveness in a new subpopulation An Investigational New Drug Application (IND) was submitted to FDA. A new animal toxicology report is obtained and will be submitted to FDA in no more than every... - ANS-information amendment submitted no more than every 30 days. Mechanisms to Amend an OTC Drug Monograph - ANS-Citizen Petition Citizen Petition Time and Extent Application (TEA) Per 21 CFR 820, a clinical study to establish a device's safety and effectiveness is considered: Verification or Validation - ANS-Validation: meets needs of users An important consideration in developing 505(b)(2) products as compared to ANDA products is: - ANSExtended market exclusivity of 505(b)(2) products. A Class II device with electrical components was subjected to extensive standardized testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device? - ANS-Abbreviated 510(k) PHS Act Section 351, Minimal or Manipulated? - ANS-Manipulated (look for terms like expanded and dmb) PHS Act Section 361, Minimal or Manipulated? - ANS-Minimal 4. A sponsor is interested in having a pre-IND meeting with FDA. When must the meeting package be submitted to the appropriate FDA review division to ensure that the reviewers have sufficient time to review the material prior to the meeting? - ANS-No later than 30 days before the scheduled date of the formal meeting Which FDA expedited program for serious conditions allows approval without demonstration of efficacy. - ANS-Accelerated Approval Your company wishes to seek approval of a combination of individually approved anti-hypertensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed combination. Which of the following regulatory pathways is most applicable? - ANS-505(b)(2) Once an Investigational New Drug (IND) is in effect, an amendment can be submitted for all the following EXCEPT: - ANS-The sponsor intends to conduct a clinical investigation with an exception from Informed Consent for emergency research A physician reports to a manufacturer a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. The manufacturer must report this event to FDA no later than: - ANS-Serious injury must be reported within 30 days; see 21 CFR 803.50(a CONTINUES....