The Food and Drug Administration (FDA) must review and approve all new drugs before they can be marketed in the United States. The FDA evaluates new drugs based on scientific evidence obtained from clinical studies and other research conducted by a drug’s sponsor, typically a pharmaceutical company. Sponsors submit this information to FDA in a new drug application (NDA).
An NDA is a formal request asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
The goals of the NDA are to provide enough information to permit FDA reviewers to make the following key decisions:
• Whether the drug is safe and effective in its proposed use(s)
• 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.
NDA documentation 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.
The review copy is divided into six technical sections:
• Chemistry, Manufacturing and Controls
• Nonclinical Pharmacology and Toxicology
• Human Pharmacokinetics and Bioavailability
• Microbiology (if required)
• Clinical Data
Each application must contain a summary, usually between 50-200 pages long, summing up all of the information in the application and providing a general understanding of the drug product and its application. It must include the most important information about the drug product and the conclusions to be drawn from this information, a factual summary of safety and effectiveness data and a neutral analysis of this data, an annotated copy of the proposed labeling, a discussion of the product’s benefits and risks, a description of the foreign marketing history of the drug (if any), and a summary of each technical section.
The summary of the NDA should include, in the following order:
• Proposed Text of Labeling for the Drug – Annotated
• Pharmacological Class, Scientific Rationale, Intended Use and Potential
• Clinical Benefits
• Foreign Marketing History
• Chemistry, Manufacturing and Controls Summary
• Nonclinical Pharmacology and Toxicology Summary
• Human Pharmacokinetic and Bioavailability Summary
• Microbiology Summary (if required)
• Clinical Data Summary and Result of Statistical Analysis
• Discussion of Benefit/Risk Relationship and Proposed Postmarketing Studies.
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness. Then, if the NDA is deemed approvable, the sponsor must provide additional information specified and defined by the FDA. The NDA will be reviewed again following the submission of the additional requirements.
Finally, if the drug is approved, throughout the life cycle of the drug, sponsors may be required to continually assess its safety during a period called postmarket surveillance or Phase 4 studies.
At Bayside Solutions, we have more than 10 years of experience providing highly talented scientists, researchers and QA professionals to the pharmaceutical, biotech, clinical and healthcare industries. For more information on the NDA process, or to find out how we can put our expertise to work for you, call Bayside Solutions today.