# Presentation: 190277

## Drug Safety InstituteCommentsFDA PDUFA IV Public MeetingFebruary 16, 2007

- Lili Stiver, RPh
- Drug Safety Institute

## Essential to industry, public and the Agency for establishing best practices & minimizing medication errors

Pleased with Agency commitment to publishing the 3 guidances

Encourage definitive timeline of 24 months after PDUFA IV implemented to publication of FINAL documents

Critical to success of pilot program shifting name testing responsibility from FDA to Industry

- Pleased with Agency commitment to publishing the 3 guidances
- Encourage definitive timeline of 24 months after PDUFA IV implemented to publication of FINAL documents
- Critical to success of pilot program shifting name testing responsibility from FDA to Industry

- 1. Guidances to Industry

## Guidances to Industry (continued) 

- Encourage Agency to expand guidance scope to include _all FDA-regulated product proprietary names_ including:
- 	- vaccines, blood products, medical devices, veterinary drugs, OTC products
- 	- also include proprietary names under which distributors/repackers market approved products

## Encourage target performance goal of 90 days for completing reviews of both INDs and NDAs

Regarding proposed phase-in percentage of submissions subject to goal (50% year one, 90% year four or program):

Request clarification on how Agency will:
determine completion of 50% to 90% of workload
assimilate current backlog into the PDUFA IV review process

- Regarding proposed phase-in percentage of submissions subject to goal (50% year one, 90% year four or program):
- _Request clarification_ on how Agency will:
- determine completion of 50% to 90% of workload
- assimilate current backlog into the PDUFA IV review process

- 2. Review Performance Goals

## Encourage Agency to adopt 90-day performance goal 
	as timeline for not only review, but also notification of 
	applicant as to review outcome

- 	as timeline for not only review, but also _notification of _
- 	_applicant_ as to review outcome

- 2. Review Performance Goals(continued)

## Commend FDA proposal to develop and implement pilot program shifting risk assessment & testing  responsibility for proprietary names from FDA to Industry

Consistent with FDA role of reviewing submitted data

Suggest FDA set a timeline for pilot program implementation that coincides with publication of final 3 guidance documents (i.e. 24 months after PDUFA IV implemented)

- Consistent with FDA role of reviewing submitted data
- Suggest FDA set a timeline for pilot program implementation that coincides with publication of final 3 guidance documents (i.e. 24 months after PDUFA IV implemented)

- 3. Pilot Program

## Suggest pilot program be open to both INDs and NDAs

Suggest Agency consider incentive, such as shorter review times, to get Industry to participate

Suggest pilot be open to all pharmaceutical and consulting companies who routinely perform risk assessments

- Suggest Agency consider incentive, such as shorter review times, to get Industry to participate
- Suggest pilot be open to all pharmaceutical and consulting companies who routinely perform risk assessments

- 3. Pilot Program (continued)

## Thank You!