The FDA Proposes Several Changes to NDA and ANDA Forms
The FDA Proposes Several Changes to NDA and ANDA Forms
The proposed changes account for recent legislative requirements and allow for the submission of additional information.
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The FDA is proposing several changes to its New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) forms and processes to account for recent legislative requirements, such as the CREATES Act, and allow for additional information to be submitted.
The proposal includes significant updates to the application procedures and requirements requiring specific data elements, patent information, pediatric use information, and specific postmarketing reports (PMRs).
Regulators say the proposed changes reflect an overall decrease in the burden hours attributed to improvements in the FDA's efficiencies and digital submission processes. This adjustment also considers the impact of the pandemic on submission numbers, with an expectation of returning to pre-pandemic levels as economic activity recovers.
Comments on the notice are open until April 5.
In case your time is short, here's a quick summary of the proposed changes.
New content and format requirements
The changes specify content and format requirements for NDAs and ANDAs, including submitting specific data elements like patent information, pediatric use information, supplements, amendments, proposed labeling, and specific PMRs. FDA says this ensures comprehensive documentation and review of all aspects of the drug's safety, efficacy, and manufacturing quality.
User fee programs and performance goals
The changes align with the FDA User Fee Reauthorization Act of 2022, which touched on performance goals, expedited programs, review transparency, communications with the FDA, and drug safety enhancements. These changes are designed to ensure that the FDA's resources are appropriately allocated to meet program objectives.
Drug Master Files (DMFs)
The FDA proposes updating Form FDA 3938 for DMF submissions to allow for multiple selections of submission types and to clarify requirements for holder and establishment registration numbers.
Accelerated approval and special circumstances
The proposed changes also cover the approval process for new drugs addressing serious or life-threatening illnesses, including the criteria for accelerated approval and the conditions under which human efficacy studies may not be ethical or feasible.
CREATES Act compliance
New measures would facilitate the CREATES pathway, which allows developers to obtain samples of brand products necessary for application support. This includes the requirement for a Covered Product Authorization for products subject to a REMS with elements to assure safe use.
New and revised forms
The FDA proposes updating and introducing various forms to assist applicants in the submission process.
These forms include FDA 356h, FDA 2252, FDA 2253, Forms FDA 3331/3331a, FDA 3542, FDA 3542a, and new forms for the transmittal of postmarketing requirements and commitments, as well as for DMF submissions and CPAs.
A few things to consider
Assuming these changes are made as stated (knowing they may change after the comment period), here are some steps impacted drug firms may want to consider.
First, in assessing the impact of these changes on upcoming submissions:
Conduct a review and ID gaps. Designate an internal group or a consultant (contact us!) to conduct a detailed review of all current and planned drug development projects against the new FDA requirements. This includes reviewing all stages of drug development, from pre-clinical studies to Phase III clinical trials. Pinpoint any additional data requirements introduced by the changes, such as more detailed pediatric use information or enhanced postmarketing surveillance data. Assess whether current studies provide this data or if new studies are needed.
Review the updated requirements for patent information submissions. Make sure your team understands any new forms or declarations required and assess the impact on your patent strategy, especially for products nearing submission.
Assess the impact on timelines. For any project in the pipeline, estimate how the new requirements might affect development and submission timelines. This includes time for gathering additional data, revising applications, and potential re-submissions. Make adjustments.
Prep for CREATES Act compliance. If you’re affected by the CREATES Act, evaluate how the requirement for obtaining Covered Product Authorizations (CPAs) could impact generic or biosimilar product development.
Second, consider updating your processes and documentation:
Revise your SOPs. Update standard operating procedures to incorporate the new FDA requirements. This could include SOPs for compiling and reviewing pediatric use data, submitting patent information, and preparing postmarketing reports.
Update your documentation templates. Revise document templates used for regulatory submissions to ensure they align with the new content and format requirements specified by the FDA. Include templates for new or revised forms required for DMF submissions and CPAs under the CREATES Act.
Enhance your data collection program. Implement or refine your data collection methodologies to ensure the collection of any additional data required under the new guidelines. This may involve modifying clinical trial protocols or adding new assessments to ongoing studies.
Train staff on updated processes. Organize training sessions for all relevant staff, including those in regulatory affairs, R&D, legal, and compliance departments. Ensure they understand the revised processes, new requirements, and how to use any updated templates or forms.
Implement a review and audit mechanism. Establish regular reviews and internal audits of submission documents to ensure compliance with the updated FDA requirements. This should include checks for completeness and accuracy of data, especially regarding the new elements required in submissions.
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