If you’re following PMTA submissions, you’ve probably seen many press releases from vape companies detailing the status of their applications. The FDA review process has multiple stages and keeping track of what a status actually means for a product can be tricky. These are the key stages that each PMTA application goes through on the way to market authorization.

SUBMISSION

Submission is the first step of the PMTA process. This status simply means that a brand has submitted their application to FDA and received a confirmation that the file package was received.

ACCEPTANCE

Acceptance indicates that FDA has performed a brief administrative review of the application and has determined that all the required documents were included as part of the application package. This does not mean that the documents are complete to the FDA’s standards, just that enough has been included to warrant a preliminary review.

Complete applications typically contain hundreds of individual documents covering everything about the product, from the details of its design and manufacture, to product-specific toxicological and clinical studies, to comprehensive consumer research and marketing plans.

FILING

Following acceptance, applications undergo a more thorough review to determine if they include the data outlined in Section 910(b)(1) of the Tobacco Control Act (TCA). A filing status will only be received by brands that have submitted an application that contains all the necessary components with enough data included to justify a complete scientific review.

Filing is a critical milestone for a brand because once this status is reached, it is legal for products to remain on market till September 2021 while FDA completes its review.

SUBSTANTIVE REVIEW

During the substantive review phase of the PMTA process, FDA performs a detailed inspection of the documents and research that a brand has provided. This review considers whether or not an applicant product is safe for consumers and if it will be manufactured and marketed to FDA standards, with the ultimate goal of determining if a product is appropriate for the protection of public health.

Substantive review typically takes 90 days from notification of entering the review phase to receiving the first set of questions and comments from the FDA. The majority of applications will receive follow-up questions and/or requests for additional data that may extend the timeline of the review phase.

MARKET AUTHORIZATION

If FDA determines that a product meets its standards for the protection of public health, that product will receive a marketing order. This allows the product to remain on the market as long as the order is active and requires that brands adhere to strict reporting timelines and notify FDA of any potential health concerns.

POST MARKET SURVELLIANCE

Marketing orders can be suspended or withdrawn if a brand fails to maintain appropriate post market surveillance reporting or if new evidence comes to light that shifts the agency’s perspective on if the product is appropriate for the protection of public health. Brands can protect their market authorizations by maintaining thorough records, performing ongoing product surveillance, and providing high quality reports to FDA.

Blackbriar Regulatory Services is a dedicated partner at every stage of the PMTA process. We walk brands through compiling data for their initial submission, to answering agency questions during substantive review, to maintaining pristine post market records.

Article written by MARA UNKEFER – Director of Consumer Research at Blackbriar Regulatory Services