RAPS RAC (Drug) Practice Test

Which of the following is NOT a reason to file an OMOR?

Switch a product from prescription to over-the-counter.

You are a manufacturer in the US, and you discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is the MOST appropriate next step?

Discuss with regulatory authorities to investigate how to have the off-label indication approved.

A pharmaceutical company is developing a new drug. Which of the following scenarios would most likely require extensive safety pharmacology studies?

It is a biotechnology-derived product that represents a novel therapeutic class.

A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test, a microhematocrit analyzer that, among other intended uses, can determine a blood donor's hematocrit prior to donation. The firm should address the 510(k) submission to:

CBER

In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier?

Quality Overall Summary

Blood Center ABC has just opened in a Midwestern state. It plans to manufacture blood and blood products from volunteer blood donors and offer these products for sale to local dialysis clinics and hospitals in other states. Blood Center ABC must:

Register with FDA within five days after beginning operations and provide a current list of all products manufactured, prepared and processed that are in commercial distribution.

FDA CDER encourages submission of a human factor's validation protocol for review prior to the execution of the study. What is the most appropriate mechanism by which a sponsor should use to get FDA's feedback on the protocol?

Submit the protocol to the IND.

Investigational combination products that include a device constituent part are subject to which provision of 21 CFR part 820?

Design Controls (21 CFR 820.30) unless the device constituent part is exempt from design controls.

Which U.S. agency makes the first assessment of a new drug's potential for addiction and/or abuse?

FDA

Which of the following statements about biosimilars is NOT correct?

Biosimilars are considered as generic pharmaceuticals and use the same marketing review procedures.

Your engineering department would like to install a different mixer for use in solid dosage forms, and validate it for interchangeable use with an existing mixer. Changing between which of the following pairs of blenders would be considered the least likely to impact product quality?

Double cone blender and bin blender

Which of the following is the purpose of an end-of-Phase 2 meeting between the IND sponsor and the FDA?

To evaluate the pivotal study design.

A regulatory professional is negotiating with the FDA on a product's final labeling. The company's management is adamant about including a claim in the labeling, while the FDA is proposing a more restrictive claim. What is the regulatory professional's BEST course of action?

Negotiate with the review division.

Within how many days after receipt MUST the FDA file, or refuse to file, an NDA?

60

What statements would NOT be correct about an Authorized Generic Drug?

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.

A regulatory professional receives a lengthy letter for a BLA indicating non-approval. Which of the following actions will restart the review clock?

Submitting the complete response.

According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of the following EXCEPT:

A PQS can be certified through the ICH Q10 Certification Programme, reducing the frequency of inspections

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?

120

The current consistent adverse drug reaction terms used for product labeling originate from which of the following?

Medical Dictionary for Regulatory Activities

A manufacturer wants to gain approval of an over-the-counter (OTC) product already approved in a Reference Member State by a competitor for a different indication. Which of the following filings are required?

File a new Marketing Authorisation Application.

Which of the following statements regarding European scientific guidelines is CORRECT?

The standards do not have legal force.

A clinical trial for a medicinal product was conducted in several European countries and has been finalized. What is the MOST appropriate next regulatory step?

File a declaration on the end of the clinical trial to the CA and ethics committees of the participating countries.

Your company is planning to place a generic, non-biologic product on the market. The original product manufacturer's data exclusivity period is over. As a regulatory professional, how will you advise your company to obtain a faster Marketing Authorisation?

To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer's file for the rest of the documentation.

What advice should the regulatory professional give a clinical trial sponsor on the content required for the label on a study drug?

For sites in the EU, the labeling must specify the period of use for the product.

A clinical investigator would like to use an investigational medicinal product to treat a gravely ill patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the clinical investigator, the product would be the best option for that patient. What action is MOST appropriate for the clinical investigator to take?

Obtain approval from the CA for compassionate use of the product for this particular patient.

A variation for a complex manufacturing change should include which of the following?

An expert statement and CV from a quality expert.

What could form part of the procedures for a non-interventional imposed PASS (Post Authorization Safety Study)?

All of the above.

Which of the following statements regarding the duties of the Qualified Person (QP) responsible for batch release is correct?

The QP is responsible for confirming the quality of medicinal products in accordance with the requirements of the Marketing Authorisation.

As per EMA Variation Guideline, when the national competent authorities or the European Medicines Agency needs to be notified of the change (submitted) immediately upon implementation, the type of variation is:

Type 1Ain

A manufacturer of an advanced therapy medicinal product verifies that its equipment used to manufacture the medicinal product adheres to user specifications and GMP requirements. These steps would NOT include which of the following:

Process Qualification (PQ)

Your company is planning to have a new drug product to be registered with local health authority and you have been tasked to prepare for pre-submission meeting. What are your courses of actions in sequence?

Check on the list of attendees for the meeting.

Which of the following is MOST appropriate for the purpose of lot release of biologics?

Quality verification

A sponsor is investigating the impact of a manufacturing process change to its cellular therapy product. After evaluating the relevant quality attributes, for which outcome can the pre-change product and post-change product be considered comparable?

The pre-change product and post-change product are highly similar. Some differences have been noted in the quality attributes of the products. No adverse impact on safety or efficacy of the product is anticipated.

What is the MINIMUM time in months of continuous use that mandates carcinogenicity testing for pharmaceuticals?

6

If there is a slight change in the drug substance storage temperature, for instance, from - 16°C ± 4°C to - 20°C ± 5°C, would you submit the change to the health authority?

Yes, submit with required documents and rationale letter.

In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

Product stability

In what module of the CTD is information on the quality of a medicinal product noted?

2

A company is developing a new chemical entity. As part of the preclinical investigations, which of the following battery of toxicity tests cannot be waived and MUST be completed?

Genotoxicity

The safety database for an anti-hypertensive drug consists of the following:

461 patients exposed for three months

343 patients exposed for six months

112 patients exposed for nine months

74 patients exposed for 12 months

Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

100 patients for 12 months

Which of the following would FDA consider to be obstructing an inspection?

The facility fails to produce requested records in a timely manner, without a reasonable explanation.

Which of the following is directly related to the stability of a product?

Expiration date

Dextromethorphan, an over-the-counter cough suppressant, has been subject to WHO discussions about scheduling as a controlled substance due to its psychoactive effects and potential for severe psychological dependence. Which of the below would you recommend as an argument against scheduling?

Strategies other than scheduling would preserve access while reducing abuse.

Which of the following is false regarding meeting minutes for formal meetings relating to biological products regulated by CBER?

For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes.

A specification deviation occurred on seven batches of a pharmaceutical product that could lead to a product recall. In which of the following activities is the regulatory professional MOST closely involved?

Developing a recall strategy.

In its Guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, issued in November 2017 and updated in July 2020, FDA announced a compliance and enforcement discretion policy to give manufacturers time to determine if they need to submit an IND or marketing application. This policy ended in May 2021.

FDA will comment, if requested, on its compliance or enforcement approach in light of this policy change.

Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

Strengthening a precaution to the product labeling.

Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of biological products?

Meetings may be electronically recorded.

Which of the following terms 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

Which of the following is false regarding orphan drug designation in the US?

FDA encourages sponsors to request designations for pediatric subpopulations, which are critical for stimulating the study of drugs in pediatric populations.

A company is developing an (unapproved) drug-device combination product but is not sure to which center it should submit its marketing application. The company should first submit:

A Request for Designation to the Office of Combination Products.

An FDA reviewer contacts a regulatory professional with a lengthy list of questions regarding a submitted 510(k) application. Some of the information is not readily available and may require additional data collection. What is the BEST course of action for the regulatory professional?

Send a letter with anticipated response time.

Which of the following is NOT a role of the FDA Office of Combination Products?

To review marketing applications of combination products.

Which of the following is not the sponsor's responsibility?

Maintaining records of receipt, use and disposition of investigational product.

Which of the following variations can be included in a single ANDA for an oral solid dosage form, assuming other parameters are the same?

Different strengths

Part way through an early-stage exploratory IND for an oncology drug trial, the Sponsor requests your regulatory advice on amending the existing Protocol to include a new subset of disease and to add a new Investigator. What scenario below BEST captures the advice you should give?

No reporting to FDA or IRB is required as the amendments to the Protocol are both considered insignificant to safety in an early-stage trial.

Which of the following is TRUE regarding expedited programs for regenerative medicine therapy products?

Advantages of the RMAT Designation include all of the benefits of Fast Track Designation and Breakthrough Therapy Designation.

A medicine for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in ___________ people in the European Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs.

10,000

A video presented during a daily television show, and accessible via YouTube, featured an interview with an influencer/spokesperson, talking about the spokesperson's experience with a prescription migraine medication. The NDA sponsor received an untitled letter from the FDA office of Prescription Drug Promotion citing false or misleading efficacy claims, false or misleading risk presentation, and failure to submit to FDA prior to dissemination. Which of the

following aspects of the video would be an example of a false or misleading efficacy claim?

This product never gave me rebound headaches.

Within _____ days of FDA approval of an NDA, the sponsor must submit the content of labeling in SPL format.

14

What would NOT be a consequence of this change of FDA policy?

FDA will comment, if requested, on its compliance or enforcement approach in light of this policy change.

Which of the following changes to an approved NDA can be implemented prior to FDA approval?

Extension of the expiration date based on shelf life obtained from the stability protocol in the approved application

Which of the following is a required record when a prescription drug is sold by a manufacturer to a chain pharmacy's warehouse?

Product and lot information

A firm can assure effective process validation for a new medicinal product best by conducting which of the following types of validation?

Prospective

A regulatory professional is requested to assist on a submission strategy for a non-innovative drug authorized in one member state. What is the BEST strategy for the extension of the license in other member states?

Use the MRP.

A detailed summary of product quality (CTD Module 2.3 Quality Overall Summary) and a declaration statement (CTD Module 1.4.1 Quality) are required as part of a Marketing Authorisation Application in the EU. Who has responsibility for signing this declaration statement?

Expert with the necessary technical or professional qualifications.

A biotechnology company is developing a follow-on biologic it claims is similar to an authorised biologic medicinal product and already available on the market. What should the regulatory professional submit with the Marketing Authorisation Application dossier?

Full quality dossier supplemented by the demonstration of comparability.

Which title of Directive 2001/83/EC, as amended, refers to the supply of samples?

Title VIIIa Information and Advertising

What is the least likely action OPDP will take in response to this promotional communication?

OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products.

A manufacturer submits a Type IA variation application for a product authorised through the Mutual Recognition Procedure. Which of the following courses of action could happen?

Within 30 days, the Reference Member State acknowledges it accepts or rejects the variation IA.

Your company is planning to have a new drug product registered with EMA, and you have been asked to seek scientific advice. In chronological order, what are the events taken place during the planning phase with preparatory meeting?

EMA appoints the representative for the meeting.

Which of the following agencies initiated a pilot program "PARALLEL SCIENTIFIC ADVICE (HUMAN MEDICINAL PRODUCTS)" to exchange their views on scientific issues during the development phase of new medicinal products?

USFDA (United States Food and Drug Administration) and EMA (European Medicine Agency).

Which term does NOT describe the same concept as the others?

Biosimilars

Follow-onprotein products

Monoclonalantibody

Subsequententry biologics

Monoclonal antibody

A regulatory professional is preparing a clinical trial application for the company's new product. During the review of the clinical protocol, operational difficulties in the execution of the protocol were discovered. What is the BEST action for the regulatory professional to take?

Ask for a consultation with the regulatory agency.

A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation. What should be done. What action should the company take FIRST?

Contact the regulatory authority that issued this request and discuss the requirement.

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

"Product X is effective for the treatment of arthritis."

Which of the following claims would classify an apple as a drug?

"It will prevent colds."

For a biological drug product regulated by CBER, FDA intends to hold a Type C meeting within how many days after receipt of a sponsor meeting request?

75

Per ICH guidelines, which of the following adverse drug reactions is subject to expedited reporting?

Anaphylaxis that is not a listed side effect of the drug.

While a company's NDA submission is under review at FDA, the US Pharmacopeial Convention issues a revised monograph involving a minor change to the company's product. Which of the following actions is the regulatory professional's MOST appropriate response?

Obtain approval for submission and submit the change in the next annual report.

Which of the following is not the sponsor's responsibility?

Maintaining records of receipt, use and disposition of investigational product.

Which of the following would require a Type A meeting with the US FDA?

Dispute resolution

A company is developing an unapproved drug-device combination product in which the primary mode of action is the drug. What application type and to which center should the company submit its application for marketing approval?

Submit a New Drug Application to CDER.

A serious adverse event of Grade 4, life-threatening hallucinations is reported by an investigator for an investigational drug in a Phase 3 clinical trial for patients with advanced stage malignant melanoma. Grade 1-3 (mild, moderate, severe) hallucinations have been reported previously in the Investigator's Brochure. You advise the medical monitor to confirm the severity grade for this AE is reported correctly by the investigator. What subsequent reporting should follow?

If AE is confirmed to be Grade 4, report as a serious and unexpected AE associated with the investigational drug to FDA via phone or facsimile within 7 calendar days, followed by a written report within 8 additional calendar days.

A company is developing an unapproved cell and gene therapy that is a combination product (device-biologic). What application type and to which center should the company submit its application for marketing approval?

Submit a Biologic License Application to CBER.

A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product that varies from the Reference Listed Drug (RLD) in route of administration, dosage form or strength. What process should be used to apply for that permission from FDA?

Suitability Petition

A firm received a raw material for one of its drug products. The raw material was placed in quarantine and sampled appropriately. Sample containers should be identified so the following information can be determined:

The material name, lot number, the container from which the sample was taken, name of person who collected the sample and the date on which the sample was taken.

On Monday, commercial stability batch testing for an approved drug produced out-ofspecification results. No assignable cause had been identified as of Wednesday. What is the best action for the regulatory professional to take?

Issue a Field Alert.

During a review of the production records for Batch 1 of Drug Product X, it was discovered the theoretical yield exceeded the maximum percentage established in the master production and control records by 1.5%. The batch has not been distributed. As a regulatory professional, you should recommend the investigation:

Be extended to other drug products that may have been associated with the discrepancy.

Clinical studies for an Investigational Medicinal Product are nearing the end of Phase 2, and the development team is actively planning Phase 3. The team is interested in seeking feedback from the Committee for Medicinal Products for Human Use (CHMP) on the proposed Phase 3 study design. As the regulatory professional on this team, what information should you offer related to Scientific Advice?

If Scientific Advice is not followed, the reasons will need to be discussed in the subsequent submission documents.

A manufacturer is sponsoring a pharmaceutical clinical trial. Before starting the trial, the clinical investigator MUST first obtain which of the following?

Approval from the ethics committee.

Regulation EC 469/2009 provides which of the following?

The opportunity to obtain an SPC.

In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

Previous actions taken by regulatory authorities on similar products.

What regulatory information is included in the Official Journal of the European Union?

Proposed and final EU legislation.

A company is developing a new line of products in an area that is new to the company. What is the BEST approach?

Summarize regulatory documents and history and provide the information to the management team.

A company has a product on the market in Country X. To ensure successful launch of the product in Country Y, which of the following resources should be examined FIRST?

Country Y's regulatory agency website.

Which of the following is BEST identified as a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality?

Design space

What is the BEST source for determining the format of an MAA intended for submission to an HA?

Local HA guidelines

Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer. What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

Enter into an agreement with Company Y to perform due diligence.

Which of the following BEST describes the purpose of the ICH?

To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions.

A drug that has currently accepted medical use, and has limited potential for abuse, physical or psychological dependence, would likely be placed in which controlled substance schedule?

Schedule IV