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FDA in Brief: FDA provides new information to clarify processes for companies related to generic drugs and other abbreviated pathways

For Immediate Release: Oct. 13, 2017

Media Inquiries

 Sandy Walsh
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 Lauren Smith Dyer
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"The creation of a more efficient path for the development and approval of generic drugs is a critical component of our efforts to promote competition and increase access to affordable medications. By providing greater clarity and direction to prospective drug applicants, we hope to help reduce the cost and barriers to bringing new generic medicines to patients," said FDA Commissioner Scott Gottlieb, M.D. "It’s important that applicants have a clear understanding of the best ways to work with the agency. The goal is first and foremost to provide companies with the information they need to successfully submit a complete application for FDA review. But when the agency determines an application doesn’t meet approval standards, companies can also learn a lot by discussing with the FDA ways in which they may be able to come back with the right information. Today’s guidances aim to provide companies with a better understanding of FDA processes for submitting applications and engaging with the FDA about application deficiencies."

To help applicants choose the best abbreviated pathway for their submission, the FDA has issued the draft guidance, Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generic Drug User Fee Amendments, to assist applicants in generating and submitting a request for a post-complete response letter meeting with the FDA to clarify deficiencies identified in a complete response letter to an abbreviated new drug application. This guidance provides procedures to promote well-managed meetings and help ensure that these meetings are scheduled and conducted in accordance with the timeframes, or performance goals, set forth in the Generic Drug User Fee Amendments II commitment letter. The meetings described in this guidance enable applicants to seek clarification concerning deficiencies contained in a complete response letter, with the goal of gaining an understanding of specific deficiencies and expectations for resolution before the abbreviated new drug application is resubmitted to the agency for review. The FDA also is providing a webinar to give an overview of this guidance.

Additionally, the FDA issued a draft guidance, Determining Whether to Submit an ANDA or 505(b)(2) Application, which serves as a foundational guidance to determine which abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act is appropriate for the submission of a marketing application for a human drug product to the FDA. The guidance highlights criteria for submitting applications under the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act. Section 505(j) is used for abbreviated new drug applications for generic drug products.  Section 505(b)(2) is used for certain new drug applications that rely on FDA findings for a previously approved application or published literature. In addition to considerations for determining which pathway is most appropriate for their proposed drug product, the guidance also provides direction to applicants on requesting assistance from the agency in making this determination. The agency is providing a webinar to give an overview of this guidance.

For More Information:

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.

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