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# FDA Wants More Efficient Drug Development Continuum
- URL: https://www.fdaweb.com/fda-wants-more-efficient-drug-development-continuum/
- Published: 2018-06-05T12:00:00.000Z
- Updated: 2026-09-15T00:10:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141611

FDA commissioner **Scott Gottlieb** says the agency is taking steps to make the entire continuum of drug development more efficient as a way to lower costs and expand opportunities for innovation. [Speaking](https://www.fda.gov/NewsEvents/Speeches/ucm609579.htm?ref=fdaweb.com) 6/2 at the annual meeting of the American Society of Clinical Oncology, Gottlieb outlined steps being taken at each stage of the drug development and review process —from clinical trial recruitment, to application submission and evaluation, and to modernizing FDA’s approach to post-market manufacturing.

He said FDA is providing additional guidance to sponsors about how to include more under-represented patients in clinical trials. One such guidance document, he said, looked at considerations for including adolescent patients in adult oncology trials. “If there’s no evidence that an investigational drug might have exaggerated toxicity in younger patients,” he said, “then we’re encouraging sponsors to enroll adolescents into disease appropriate trials.”

He also discussed two new pilot programs. The first is aimed at trying to focus submissions more squarely on data that are most relevant to assessing safety and effectiveness, and not be obscured by excessive documentation or superfluous information that doesn’t inform key decision-making. The second pilot is a voluntary submission form that an applicant uses to facilitate FDA assessment of a drug application. Gottlieb said this is being used in the review of supplemental applications. “Under this templated approach to receiving applications,” he explained, “we’ll be using the sponsor’s structured file, which follows a new template format that we’re piloting, as the basis for our review…. Under this approach we’ll annotate the sponsor’s drug file with our assessment rather than creating a separate document that recapitulates many of the same data tables.”

Gottlieb also said that within another week, FDA will announce “a major proposed modernization of our entire new drug review process.”