Premarket Tobacco Product Application (pmta) Review Process


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PREMARKET TOBACCO PRODUCT APPLICATION (PMTA) REVIEW PROCESS
Presented by: Nicholas Hasbrouck Regulatory Health Project Manager Division of Regulatory Project Management Office of Science Center for Tobacco Products U.S. Food and Drug Administration
Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy.
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AGENDA

• Statutory Requirements

• Review Process

- Pre meeting

Pre meeting

- Acceptance

Acceptance

- Filing

Filing

- Review

Review

- Postmarket Reports Reporting

• Metrics

• Key Features

• Helpful Resources

Action

1 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

STATUTORY REQUIREMENTS, SECTION 910

2 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

STATUTORY REQUIREMENTS
• Under section 910(a)(2) of the Federal Food, Drug, and Cosmetic Act, an order is required for a new tobacco product to be introduced and legally marketed in the United States
• PMTA is the primary pathway to market

3 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

STATUTORY REQUIREMENTS
• The standard required to be met for a PMTA is if marketing of the product is “appropriate for the protection of public health”, section 910(c)(4)
- Considers risks and benefits to the population as a whole:
 Impact on cessation  Impact on initiation
• The product must conform to any requirements of section 906(e) (manufacturing practices) which apply (if any)
• The proposed labeling must not be false or misleading • The product must conform to product standards under section 907 which apply (if any), or
must contain an adequate justification for such deviations

4 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

PMTA REVIEW PROCESS

5 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

PMTA REVIEW PROCESS

Phase 0
Pre-PMTA meetings

Phase 1 Acceptance

Phase 2 Filing

Phase 3

Review

Action

Phase 4
Postmarket Reporting

6 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

PRE-PMTA MEETING (PHASE 0)
• Pre-meeting
- Forum to discuss and receive feedback prior to submitting your application - Most useful to be held well in advance of the planned pre-market submission - May result in a more complete application

 Guidance - Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised July 2016)

Premeeting

7 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

ACCEPTANCE (PHASE 1)

• Ensure the product falls under CTP jurisdiction
• Confirm the regulatory requirements of an application are included in submission
• Expected outcome:
- Accepted and Acknowledged or
- Refuse to Accept
• If the application is accepted, it moves to Filing phase

 Final Rule - Refuse To Accept Procedures for Premarket Tobacco Product Submissions

Acceptance

8 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

CENTER FOR TOBACCO PRODUCTS

FILING (PHASE 2)

1. Full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products
2. A full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product
3. A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco
product

9 October 22-23, 2018 | Tobacco Product Application Review Public Meeting | PMTA

Filing
CENTER FOR TOBACCO PRODUCTS

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Premarket Tobacco Product Application (pmta) Review Process