This also includes the investigator. A principal investigator may be on a review board, however, they are not allowed to vote on submitted matters.

Module 1 is not harmonized as it is region specific. Module 2: ICH M4Q(R1) Quality Overall Summary (QOS) -- summarizes data in Modules 3,4, and 5. Module 3: ICH M4Q(R1) Quality -- contains Chemistry, Manufacturing and Controls (CMC) information Module 4: M4S(R2) Safety -- includes information regarding pharmacology, pharmacokinetics, and toxicology. Module 5: M4E(R1) Efficacy -- contains study reports

The applicant is anyone who submits an application or abbreviated application or an amendment or supplement to them in order to obtain FDA approval or any person who owns an approved application or abbreviated application.

The application form that is to be completed and signed by the applicant is the New Drug Application (NDA).

The following items must be disclosed when submitting patent information: A. New Drug Application (NDA) number B. Name of new drug application sponsor C. Trade name (or planned name) D. Active ingredient(s) E. Strength(s) of new drug F. Dosage form G. US patent number, issue date, and expiration date of patent submitted H. Patent owner's name, address, phone number and if available fax number and email address I. Agent of Representative in the US's name, address, phone number and if available fax number and email address J. If the patent has been submitted before K. If the expiration date is new or from a previous patent L. Information on whether the product is novel M. Information on drug substance N. Information on drug product O. Information on method of use P. Confirmation there are no relevant patents that claim the drug substance, drug product, or methods of use, for which the applicant is seeking approval with respect to which a claim of patent infringement could be asserted Q. Signed verification R. Information on who signed the form their name, address, phone number, and if available fax number and email address.

The CTD is the format in which NDAs should be completed. According to the CTD information from 314. 53 regarding patent information and certification is included in Module 1 of the NDA.

It is essential that the applicant understands the difference between an application and an abbreviated application. While an application and an abbreviated application are very similar in definition, an abbreviated application is just that abbreviated. Thus meaning that all the aspects of an application are not included in an abbreviated application. In an application there must be a statement that confirms the type of application, such as original application, 505(b)(2) application, resubmission, or a supplement to an application; whereas in an abbreviated application, this statement is not included. It is also important to comprehend the different types of applications and when they should be used prior to starting one to ensure the correct type will be submitted.