The United States is the world’s largest pharmaceutical market, accounting for nearly half of the global market. In 2023, it is projected to maintain its leading position, with a market share of 43.72%. The Food and Drug Administration (FDA) is the primary regulatory agency responsible for drug approval in the United States.

The Drug Approval Process

The Center for Drug Evaluation and Research (CDER), a division of the FDA, oversees the approval process for most drugs. The process begins with the submission of an Investigational New Drug (IND) application. If preclinical trials demonstrate the drug’s safety, the sponsor can submit an IND application to the FDA to begin clinical trials in humans.

The Pre-IND assessment allows sponsors to discuss various issues with the FDA, such as the design of animal research, the clinical trial protocol, and the manufacturing and control of the investigational drug. The IND requirements include various forms, protocols, chemistry, manufacturing and control information, pharmacology, and toxicology information. The FDA typically approves INDs within two years.

NDA and ANDA Submissions

Once a drug has successfully passed all three phases of clinical trials, the sponsor can file a New Drug Application (NDA). The NDA must include all animal and human data, analyzed data, the pharmacokinetics of the drug, and its manufacturing and anticipated label. The CDER reviews the preclinical and clinical reports and performs a risk-benefit analysis. The NDA submission requirements include two copies of the application: archival and review copies. The archival copy serves as a reference source for FDA reviewers, and each technical section is separately bound in each folder in the review copy.

A 505(b)(2) application is one for which some of the data used to support approval was not generated by the applicant or for which the applicant does not have the right to use. An example of a 505(b)(2) application is a change in the route of administration. Sponsors can submit 505(b)(2) applications for New Chemical Entities (NCEs) when they rely on data from studies not conducted by or for them and to which they do not have the right of reference.

For previously approved drugs, an Abbreviated New Drug Application (ANDA) may be filed. ANDAs rely on the FDA’s finding of the safety and effectiveness of the previously approved product, along with the information needed to support the change from the approved product. The FDA’s CDER is responsible for the approval of generic drugs and ANDAs. The approval process for NDA 505(b)(2) follows the same process as NDA approval. CDER aims to review and act on at least 90% of NDAs for standard drugs within ten months.

RABT’s Regulatory Expertise

RABT provides comprehensive regulatory support services to assist sponsors in compiling and submitting their NDAs and ANDAs in accordance with FDA requirements. RABT’s expertise helps facilitate timely and successful submissions for all types of applications.