New Drug Applications (NDA) is very complex and detailed. It is difficult to know whether a company has included all of the information that is required by the applicable regulations.

The Application Form

Every application must be accompanied by a completed application form FDA 356h.

The application form should be signed by the applicant, or the applicant’s attorney, agent or other authorized official.

If the person signing the application form does not reside or have a place of business within the U.S

The application must contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the U.S.

The application from along with the cover letter, letters of authorization (if any), Index and Summary should be packaged together and bound in a single volume.

These items will also be included with each separate review section.

Patent information on the applicant’s drug and any patent certification with respect to the drug should be submitted on a separate piece of paper and attached to the application form.

Index

An application must contain an index of all the elements of the application.

For each element of the application, the index must identify the volume and page number.

Each review section must contain an index specific to that review section

Check list of New Drug Applications