TheCTDtriangle
The ICH guidelines categories for each CTD Module are listed below:
Module 1: Contains administrative information and prescribing information. Module 2: Contains an overview and summary of modules 3 - 5. Module 3: Contains ICH M4Q(R1) - This code is for Quality. Module 4: Contains ICH M4S(R2) - This code is for Safety (non-clinical study reports). Module 5: Contains ICH M4E(R1) - This code is for Efficacy (clinical study reports).
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Application form
The application form that is to be completed and signed by the applicant is the New Drug Application (NDA).
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Applicant
Applicant means any person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application.
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§314.53 Submission of patent information.
The following must be disclosed when submitting patent information.
A) New Drug application number B) Name of new drug application sponsor C) Trade name (or proposed trade name) of new drug D) Active ingredient(s) of new drug E) Strength(s) of new drug F) Dosage form of new drug G) United States patent number, issue date, and expiration date of patent submitted H) The patent owner's name, full address, phone number and, if available, fax number and e-mail address I) The name, full address, phone number and, if available, fax number and e-mail address of an agent or representative who resides or maintains a place of business within the United States authorized to receive notice of patent certification under sections 505(b)(3) and 505(j)(2)(B) of the act and §§314.52 and 314.95V J) Information on whether the patent has been submitted previously for the new drug application K) Information on whether the expiration date is a new expiration date if the patent had been submitted previously for listing L) Information on whether the patent is a product-by-process patent in which the product claimed is novel M) Information on the drug substance (active ingredient) patent N) Information on the drug product (composition/formulation) patent O) Information on each method-of-use patent P) Whether there are no relevant patents that claim the drug substance (active ingredient), drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product Q) Signed verification R) Information on whether the applicant, patent owner or attorney, agent, representative or other authorized official signed the form; the name of the person; and the full address, phone number and, if available, the fax number and e-mail address
CTD is related to 314.53 as CTD is the format the NDA application should be submitted and this particular section is information that is included in the NDA application.
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§314.3 Definitions.
The terms that I feel are important to understand before submitting are applicant, application, act, abbreviated application, approval letter, resubmission, complete response letter and specification. It is crucial that the applicant truly understands what is needed prior to submitting, in addition, understanding which application is needed. The next section the application would need to thoroughly understand is Section 314.50.
1.2 Adverse Event (AE)
How often does a monitor find onsite that Principal Investigators are not reporting AEs to the Sponsor or IRB?