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NDA Primer
Components of the NDA
Preclinical Information
Clinical Testing Information
CTD Modules
100
This section of the Code of Federal Regulations outlines the primary content and format of the NDA.
What is 21 CFR 314.50
100
This form contains information about the sponsor, the drug and the proposed indication, as well as a checklist of the items contained in the NDA.
What is FDA Form 356h
100
The reports of any studies used to determine safety in preclinical studies should include this statement.
What is the good laboratory practice statement (21 CFR 314.50(d)(2)(v) and 21 CFR Part 58).
100
This element within the NDA Clinical Data section should include ADME studies, pharmacodynamic dose range, and dose response studies, and any other studies of the drug's action.
What is Clinical Pharmacology.
100
This section describes how the the drug substance and the drug product are manufactured and how the consistency of their quality will be assured from batch to batch. It is module 3 in the CDT and known as the __________ section.
What is the Quality section.
200
In accord with the provisions of the Prescription Drug User Fee Act (PDUFA), the FDA has ___ days from date of receipt to decide whether to review the NDA.
What is 60 days
200
There are # different items that may be required for a New Drug application submission to the FDA.
What is 20.
200
This type of study includes studies that were designed to define the release rate of a drug substance from the dosage form, as well as to assure consistent batch-to-batch behavior.
What is In vitro studies.
200
Information about how the drug derived from clinical pharmacology studies led to critical features of the clinical studies is included in this element of Clinical Data section of the NDA.
What is Background/overview of Clinical Investigations.
200
The CTD format was developed and agreed upon by the parties involved with the ________________________.
What is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
300
Once the application has been accepted for review, or "filed," there are 3 possible outcomes. These outcomes are _____________, _________________, or ____________.
What is "approvable" (sponsor must resolve additional issues and then can market); "approved" or "nonapprovable"
300
Under Section 306(k)(1) of the Food Drug and Cosmetic Act, an NDA must contain a statement certifying that the applicant did not and will not use in any capacity the services of any person debarred by the FDA. In what section of the NDA would the sponsor include this information?
What is Debarment Certification section; Section 16.
300
The data in this section of the NDA is provided first for males, following by females, then groups.
What is Nonclinical Pharmacology and Toxicology.
300
This section includes descriptions and documentation of mathematical analyses performed to evaluate the controlled clinical trials and other safety information.
What is Statistics.
300
This module within the CTD is not really part of the CTD.
What is Module 1: Administrative and Prescribing Information.
400
The statute governing the NDA process requires that the article be __________________ and __________________.
What is safe for use and effective for use.
400
This form provides a cross reference to the user fee paid by the applicant.
What is the User Fee Cover Sheet.
400
Protein binding, tissue distribution, accumulation - are the information that must be presented in this section of ADME.
What is D - Distribution
400
Substantial evidence of effectiveness for each claimed indication (evidence supporting the dosage and administration section of the labeling, dosage and dose interval recommended, evidence regarding individualization of dosing) is the purpose of this key section of the NDA.
What is Integrated Summary of Effectiveness data.
400
Human pharmacokinetics, microbiology, statistical section, and CRF - are included in this CTD module.
What is Module 5 - Clinical Study Reports.
500
The PDUFA is reauthorized under which amendment?
What is the Food and Drug Administration Amendments Act of 2007.
500
Under the CMC section of a NDA - what should be included when the sponsor is discussing about drug substance analytical controls? - 6 items
What are (1) specifications, (2) methods, (3) rationale for methods/specifications, (4) method validations, (5) batch analytical data, (6) sampling plan.
500
Influence of demographic characteristics such as age, gender, or race; certain disease states; or external factors such as meals or other drugs are the information from this type of preclinical study.
What is pharmacokinetics studies.
500
This section contains the forms for each patient who were dropped from the study because of an adverse event.
What is Case Report Forms.
500
Sponsor who plans on submitting an eCTD to the FDA must submit the application according to the specifications developed by _________________.
What is ICH M2 EWG.