The US Food and Drug Administration (FDA) has published two final guidances for generic drug sponsors that the agency says will streamline the premarket review and approval process.
On 24 January, FDA published two guidances as part of its Drug Competition Action Plan (DCAP). According to the agency, the objective is to streamline the generic drug review process without compromising regulatory rigor to help bring new generics to market and increase competition.
“An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines,” said FDA in a statement announcing the guidances.
FDA finalized its guidance that details the parameters abbreviated new drug application (ANDA) sponsors need to follow when updating the labeling of their product after the reference listed drug (RLD) label has been revised.
“This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling,” said the agency. “This guidance revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000).”
The most recent draft version of the guidance was published in 2022, along with several other guidances as part of FDA’s DCAP. It replaces the April 2000 guidance and some of the major changes from the previous guidance, include how sponsors can obtain information on changes to the RLD labeling and how to submit their ANDA labeling changes for FDA approval.
“The final guidance provides clear expectations for when updates to labeling are required, the process for updating labeling, and the types of submissions for labeling updates,” said FDA.
FDA also revised its final guidance on amendments and requests for final approval for tentatively approved ANDAs.
“This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (“earliest lawful ANDA approval date”),” the agency said.
The previous final version of the guidance was released in September 2020. It details the agency’s policies based on performance goals agreed with industry under the latest Generic Drug User Fee Amendment (GDUFA III) deal. It also discusses how the agency plans to address ANDA sponsor requests for final approval that meet GDUFA III expectations, and clarifies the patent certification process and exclusivities and how they may affect ANDA approval times.
“The timing of ANDA approval depends on, among other things, the patent and/or exclusivity protections for the RLD,” said FDA. “An ANDA must contain an appropriate patent certification for each patent that claims the RLD or a method of using the RLD for which the ANDA applicant seeks approval in its ANDA and for which the NDA applicant is required to submit information.”
The agency notes that the sponsor has to submit one of four certifications to FDA regarding the patent in question, including a certification that the patent information has not been filed, a certification that the patent has expired, a certification on when the patent will expire, or a certification that the patent is invalid, unenforceable or willing to be infringed by the patent-holding manufacturer.
FDA notes that if a sponsor submits the first two types of certifications, it will not delay their ANDA approval. However, if a sponsor submits the third kind of certification, they will have to wait until the patent has expired. Sponsors may also challenge a patent or argue that the patent-holding manufacturer is willing to allow their patent to be infringed by submitting the fourth kind of certification.
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