Innovative Product Development and Review

FDA report outlines initiatives to improve regulatory environment

On 31 January 2003 the US FDA released a report entitled Improving Innovation in Medical Technology: Beyond 2002 , which details several new initiatives aimed at expediting the development and review of innovative technologies¹. The aims of the initiatives, which will involve CBER, CDER, CDRH and CVM, include the following:

Measures to improve product review

The FDA hopes to reduce the length of time taken to complete device reviews in two ways:

Reducing deficiencies in applications

It intends to achieve this through a number of measures including:

• publication of additional guidance on FDA expectations for pre-market 510(k) submissions (particularly Special Control Guidance Documents);
• revision of the PMA filing guidance document in order to avoid filing of submissions that are not ready to be reviewed;
• increased attendance of reviewers at trade meetings in order to communicate FDA expectations and requirements;
• increased use of international recognised standards;
• enhanced early communication between the FDA and industry during the product development phase; and
• identification of `root causes' of review delay.

Optimising the review process

The agency also intends to address delayed reviews by adopting a quality systems approach to medical product reviews through:

• publication (in 2003) of the Good Review Management Principles (GRMPs) to provide clear guidance to ensure that the goals of improved communication are met;
• enhanced reviewer training on good review practices and increased attendance at professional meetings to keep staff updated on the latest technologies;
• peer review within the FDA review process;
• further development of review standards; and
• a quality assurance programme that will use performance measures to assess the quality of pre-market reviews and improve CDRH technology to facilitate electronic submissions.

Measures to promote innovation

Finally the agency hopes also through these initiatives to facilitate the development of innovative technology. It intends to achieve this by:

• clarifying the regulatory pathway in emerging areas including pharmacogenomics /pharmacogenetics and novel drug delivery systems (details outlined in Table 1);
• provision of clear and adequate guidance on what data the agency will need to review these products and how that data might best be collected; and
• developing guidance on clinical trials for products to treat specific diseases beginning with diabetes and obesity (within two years).

Table 1. Measures to clarify the regulatory pathway in emerging areas

Pharmacogenomics/pharmacogenetics

• · a workshop (in 2003) on issues involved in co-development of a pharmacogenomic test and a drug; and
• · development of joint CDRH/CDER guidance (within 18 months) on review components for sponsors of these products guiding them through the regulatory process.

Novel drug delivery systems

• · development of a CDRH working group to analyse review issues related to current drug delivery systems;
• · development of the best methods for animal and human testing of novel drug delivery systems;
• · development of documents (draft MOU, guidance and concept papers) within 12 months discussing ways to improve the efficacy of regulating drug delivery systems; and
• · provision of clear and adequate guidance on what data the agency will need to review these products and how that data might best be collected.

 

References

1. FDA News, P03-05, 31 January 2003, www.fda.gov

2. Improving Innovation in Medical Technology: Beyond 2002-Executive Summary, 31 January 2003, www.fda.gov