The US Food and Drug Administration (FDA) has issued two draft guidances relating to the submissions of abbreviated new drug applications (ANDAs) under the Generic Drug User Fee Amendments of 2012 (GDUFA).
The first guidance, Guidance for Industry: ANDA Submissions—Prior Approval Supplements Under GDUFA, is intended to assist applicants preparing to submit to the FDA prior approval supplements (PASs) and amendments to PASs for ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance explains how GDUFA relates to PAS submissions. The guidance also describes performance metric goals outlined in the GDUFA Commitment Letter, which FDA has agreed to meet and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals. Specifically, this guidance describes how the GDUFA performance metric goals apply to:
- A PAS subject to the refuse-to-receive (RTR) standards
- A PAS that requires an inspection
- A PAS for which an inspection is not required
- An amendment to a PAS
- Other PAS-related matters
The second guidance, Guidance for Industry ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA,
is intended to assist applicants preparing to submit amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act 19 (the FD&C Act) by explaining how the performance metric goals established as part of the Generic Drug User Fee Amendments of 2012 (GDUFA) apply to these submissions. Specifically, this guidance does the following:
- Describes the Tier system for the different types of amendments
- Explains how different types of amendments may affect the application’s original review dates
- Explains FDA’s performance metric goals based on the different amendment Tiers
- Explains the process for submitting amendments
- Describes the request for reconsideration process for FDA classification decisions.
When finalized, this guidance will replace the December 2001 guidance for industry, Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications in consideration of the new amendment review Tier system and performance goals under GDUFA.
For purposes of FDA’s performance goals under GFUDA, the Commitment Letter classified amendment types into Tiers, which have associated performance metric goals, some of which will extend the applications original review date. Each Tier has corresponding performance metric goals, ranging from a three-month review clock to a no-goal date, depending on the amendment’s classification. The Tier system takes the following factors into consideration: whether an amendment is solicited or unsolicited; whether it is major or minor; the number of amendments submitted to the ANDA or PAS; and whether an inspection is necessary to support the information contained in the amendment.
Performance metric goals establish predictability in FDA’s review process. The Tier system creates strong incentives for applicants to submit high-quality original submissions. Incomplete or poor-quality applications often result in multiple review cycles that extend or eliminate the review clock altogether. For example, if an applicant must submit a second major amendment to an application, that application loses its review goal date. Applicants are strongly encouraged to submit complete, high-quality original applications, making later amendments unnecessary.
Source:FDA Guidance for Industry: ANDA Submissions—Prior Approval Supplements and Guidance for Industry ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA