February 17 2023
On February 17, 2023, FDA published a new draft guidance for industry, “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.”
FDA issued this guidance as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process. An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines that can, in turn, help consumers lower their health care costs.
The FDA holds product-specific guidance meetings with Abbreviated New Drug Application (ANDA) applicants under the Generic Drug User Fee Amendments (GDUFA) program. These meetings provide an opportunity for the FDA to provide guidance to the applicant regarding specific products and to facilitate communication between the FDA and the applicant.
The purpose of these meetings is to address specific issues related to the development and approval of a generic drug product. Some of the issues that may be discussed in a product-specific guidance meeting include:
Quality and safety concerns related to the proposed drug product.
Comparative bioavailability and bioequivalence studies.
Proposed labeling and drug product formulation.
Manufacturing and testing processes.
The meetings are typically held after the applicant has submitted an ANDA for review. The applicant may request a meeting at any time during the development and review process, but it is recommended to do so early in the process to address any issues before the submission of the ANDA.
To request a product-specific guidance meeting, the applicant must submit a meeting request to the appropriate review division within the FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER), along with the necessary supporting documents. The FDA will then evaluate the request and determine whether a meeting is necessary.
Overall, product-specific guidance meetings can help streamline the drug development and approval process by allowing for open communication between the FDA and the applicant.
For more information, see the https://www.fda.gov/guidance
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