New Drug Application

 What is New Drug Application?

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

• Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

• Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

• Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.

Content of an NDA:

Cover Letter

• Not officially part of the NDA content and format
• Vitally important
• Opportunity to give overall strategy and remind FDA of important events that occurred during development

Summary

• General understanding of the application
•  Annotated labeling text identifying supporting information from technical section of NDA

Chemistry, Manufacturing, and Controls (CMC)

• Drug substance and drug product

Non-Clinical Data

• Animal and in vitro studies
• Pharmacology/toxicology
• Statement of compliance with GLPs
• Pharmacokinetics/Bioavailability
• In humans

Microbiology

• Only for anti-infectives

Clinical Data

• Description and analysis of studies
• Summary of efficacy and safety
• Benefits outweigh risks
• Safety updates

Statistical

• Description of statistical analysis to evaluate the data

Pediatric Use

• Pediatric rule (requiring pediatric assessment unless waived or deferred)

Samples and Labeling (and Packaging, if Requested by FDA)

• FDA validation of analytical procedures
• Labeling (package insert and patient labeling)

Case Report Forms

• Tabulations of clinical data
• Case report forms for deaths, adverse events

Patent Information

• Information for Applicant’s own patents (21 CFR 314.54)
• Certification for other patents (21 CFR 314.50(h))
• No process patents

Disclosure/Certification

• Investigator financial certification
• Debarment certification
• Claimed exclusivities
• Compliance with clinical trial disclosure requirements