News & Events

FDA In Brief: FDA takes new actions to reduce the time that it takes for safe and effective new and generic drugs reach the market

September 24, 2018

Media Inquiries

  Lyndsay Meyer
  240-402-5345

“As part of our ongoing efforts to lower drug prices and improve access to innovative medicines, the FDA is issuing two guidance documents to assist both FDA staff and industry in ensuring that the new drug review process and the generic drug review process is managed in a consistent, transparent and efficient manner. These efforts are part of our Drug Competition Action Plan. A key objective is to reduce barriers to generic drug access. As part of that goal, we want to reduce the number of cycles of review that generic applications undergo in order to make the generic approval process more efficient and shrink the time it takes for a safe and effective generic drug to reach the market,” said FDA Commissioner Scott Gottlieb, M.D. “We’ve been implementing measures to improve the efficiency of our reviews and to prioritize applications for generic versions of medicines that may lack competition. But we’re also continuing to look at how we can assist companies in submitting higher-quality and more complete applications that are less likely to undergo multiple cycles of review before receiving FDA approval. For example, historically, it’s taken about four cycles of review for an Abbreviated New Drug Application to reach approval. These additional review cycles weren’t always needed because the product didn’t meet the agency’s standards for approval. Often it was because the application was submitted without all the information necessary to prove that the generic drug meets the requirements for approval and not because the product itself was deficient. These multiple cycles of review are costly and inefficient. The guidance that we’re issuing today seek to reduce application cycling by clarifying for industry how they can submit complete, high quality applications from the start.”

By taking steps to make sure that sponsors have clear, transparent guidance on how to submit applications that are more likely to be successfully evaluated on a first cycle of review, the FDA can facilitate more complete reviews, and help manufacturers improve their ability to gain FDA approval earlier. To help industry and the agency to meet these goals, today the FDA issued two guidances designed to assist industry with preparing applications to help ensure an efficient review process.

The FDA today issued the final guidance, “ANDA Submissions – Content and Format of Abbreviated New Drug Applications,” intended to assist generic drug developers in preparing a complete and fileable abbreviated new drug application (ANDA) for FDA review. The guidance document incorporates comments received since the draft guidance was issued in 2014. The new document outlines the information for applicants to provide in each section of the portion of the ANDA known as the “common technical document” or CTD format. The guidance identifies supporting guidance documents and recommendations to assist applicants in preparing more complete, high quality ANDA submissions.

The FDA also issued the draft guidance, “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications” to assist both FDA staff and industry in ensuring the new drug review process is managed in a consistent, transparent and efficient manner. The goal of the objective, clear and structured review approach, outlined in this guidance is to decrease the number of review cycles necessary for approval and enhancing patients’ timely access to important therapies. This guidance also clarifies the roles and responsibilities of review staff in managing the review process and identifies ways in which applicants may support an efficient and robust review process.

The guidances are part of the FDA’s Drug Competition Action Plan. That plan promotes increased competition and lower drug prices through policies that, among other things, streamline the ANDA assessment process and prioritize review of certain generic medicines that lack adequate competition.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Page Last Updated: 09/24/2018
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