12-23

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Questions and Answers

What type of protocol related to PDUFA products is eligible for special protocol assessment under the PDUFA goals?

Formulation protocols

Final product stability protocols (correct)

Packaging protocols

Laboratory protocols

Why would a drug company receive a communication from the FDA stating that their new drug application (NDA) will not be approved in its present form?

Due to cost concerns

Due to issues with the drug's effectiveness

Due to manufacturing problems

Due to regulatory issues (correct)

What does the Center for Devices and Radiological Health focus on?

Human subjects protection

Devices and radiological health (correct)

Pharmaceutical manufacturing

Biologics licensing

Which type of trials are eligible for special protocol assessment under the PDUFA goals?

Phase 3 trials Signup and view all the answers

What type of protocols related to PDUFA products is NOT eligible for special protocol assessment under the PDUFA goals?

Laboratory testing protocols Signup and view all the answers

In what context would a manufacturer be required to assess the safety and effectiveness of drug products in pediatric patients?

Pediatric studies Signup and view all the answers

What type of PMA is specifically designed for devices with well-known technology and use to the FDA?

Streamlined PMA Signup and view all the answers

What is the purpose of communicating FDA's decision to a drug company regarding their new drug application?

To deny approval Signup and view all the answers

Which type of study is used as the primary basis for an efficacy claim according to the text?

$Phase$ $3$ $clinical$ $trials$ Signup and view all the answers

Under which act were fees established for Premarket Approval applications, supplements, and 510(k) submissions, with the FDA committing to strict performance goals for medical technology reviews?

MDUFMA of 2002 Signup and view all the answers

Which type of meeting is scheduled within 60 days of FDA receipt of a written meeting request and includes Pre-IND meetings and Pre-new drug application meetings?

Type B Meeting Signup and view all the answers

What is the name given to a submission to an approved application reporting changes that have moderate potential to adversely affect drug product identity, quality, and potency?

CBE-30 Signup and view all the answers

Which type of meeting involves certain end-of-phase 1 meetings as per 21 CFR 312.82 regulations?

Type B Meeting Signup and view all the answers

What is the term used for the date by which a Streamlined PMA needs to be submitted to the FDA?

Submission Deadline Signup and view all the answers

'Changes Being Effected in 30 days' should be submitted to the FDA at least how many days before product distribution?

45 days Signup and view all the answers

'Type B meetings' are specifically NOT related to which one of the following types of meetings?

$Phase 4 Meeting Signup and view all the answers

What type of articles are excluded from the definition provided?

Soap Signup and view all the answers

In FDA regulations, can they order to delay or suspend clinical investigations?

No Signup and view all the answers

Which type of device is classified as low-risk and requires general controls to ensure safety and effectiveness?

Class I Device Signup and view all the answers

How do devices receive marketing permission through the 510(k) process?

By demonstrating substantial equivalence to a pre-amendment device Signup and view all the answers

What is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans called?

Drug Signup and view all the answers

Is an Investigational New Drug Application (IND) required for research purposes?

Yes Signup and view all the answers

What does 'Substantially Equivalent' refer to?

SE Signup and view all the answers

What does ADME stand for in pharmaceutical studies?

Absorption, Distribution, Metabolism, and Elimination Signup and view all the answers

What is the acronym for the Common Technical Document used for drug submissions across the US, EU, and Japan?

CTD Signup and view all the answers

What is the official communication from the FDA informing an NDA or BLA sponsor of an agency decision called?

Action Letter Signup and view all the answers

Which statement is true about the Consent Form (CF or ICF)?

It is used for devices classified as Class III but found to be 'not substantially equivalent.' Signup and view all the answers

What is the purpose of conducting studies and clinical trials as per the text?

To fulfill sponsor requirements under statutes or regulations. Signup and view all the answers

Is it true that the single mode of action of a combination product determines its FDA center assignment?

False, the mode of action does not impact FDA center assignment. Signup and view all the answers

Does the Division of Medication Error Prevention and Analysis belong to CBER?

True, it is part of CBER. Signup and view all the answers

Is firm-initiated removal or correction exempt from legal action by the FDA?

True, it can involve significant FD&C Act violations without repercussions. Signup and view all the answers

What is a Device Master File analogous to, based on the information provided?

A submission to the FDA for detailed information about a medical device. Signup and view all the answers

Study Notes

Premarket Approval Application (PMA)

A Streamlined PMA is for a device with well-known technology and use to the FDA.

Medical Device User Fee and Modernization Act (MDUFMA)

Established fees for Premarket Approval applications (PMAs), supplements, and 510(k) submissions.
FDA committed to strict performance goals for medical technology reviews.

Type B Meetings

Scheduled within 60 days of FDA receipt of a written meeting request.
Includes pre-investigational new drug application (pre-IND) meetings, end-of-phase 1 meetings, end-of-phase 2 and pre-phase 3 meetings, and pre-new drug application/biologics license application meetings.

Changes Being Effected (CBE)

A submission to an approved application reporting changes with moderate potential to adversely affect drug product identity, strength, quality, purity, and potency.
Must be received by FDA at least 30 days before product distribution.

Cosmetic Definition

Articles intended for use in cleansing, beautifying, promoting attractiveness, or altering appearance, except soap.

FDA Order

An order to delay proposed clinical investigation or suspend an ongoing investigation.

510(k) Process

Devices receive marketing permission through demonstrating substantial equivalence to a pre-amendment device or another device reviewed under section 510(k) of the FD&C Act.

Investigational New Drug Application (IND)

A submission to conduct clinical investigations on a new drug or biological product.

ADME

The study of the process of Absorption, Distribution, Metabolism, and Excretion of chemicals and medicines.

A document that provides informed consent for subjects participating in clinical trials.

De Novo Classification

A route to market for medical devices that are low to moderate risk, but have been classified in Class III because FDA has found them to be "not substantially equivalent" (NSE) to legally marketed predicate devices.

Studies and Clinical Trials

Sponsors are required to conduct under one or more statutes or regulations.

Combination Product

The single mode of action that provides the most important therapeutic action of the combination product.

Division of Medication Error Prevention and Analysis (DMEPA)

A division responsible for medication error prevention and analysis.

Firm-Initiated Correction

A removal or correction of a device, drug, or biologic product involving a minor violation of the FD&C Act, not subject to legal action by FDA.

Device Master File

A submission to FDA that provides confidential detailed information about a medical device or a component used in the manufacture of a medical device.

Protection of Human Subjects

Regulations and guidelines for protecting human subjects in clinical trials.

Center for Devices and Radiological Health (CDRH)

A center responsible for ensuring the safety and effectiveness of medical devices.

Not Approvable Letter

Communicates FDA's decision to a drug company that its new drug application (NDA) or abbreviated new drug application (ANDA) will not be approved in its present form.

Special Protocol Assessment

A process for the FDA to review and agree on specific protocols related to PDUFA products, including animal carcinogenicity protocols, final product stability protocols, and clinical protocols for phase 3 trials.

Pediatric Research Equity Act (PREA)

Requires manufacturers to assess the safety and effectiveness of certain drug and biological products in pediatric patients.

Class I Device

A low-risk device requiring general controls to ensure safety and effectiveness.

Definition of a Drug

Any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.

Substantially Equivalent

A term used to describe a device that has the same intended use and technological characteristics as a legally marketed device.

Common Technical Document (CTD)

A standardized format for drug submissions across the US, EU, and Japan, now known as the electronic CTD (eCTD).

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Description

Test your knowledge on the classification of medical devices and drugs based on safety regulations. Questions cover topics like Class I devices, drugs for disease treatment, substantial equivalence, and common technical documents for drug submissions.