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# General Support for Draft PDUFA 6 Letter
- URL: https://www.fdaweb.com/general-support-for-draft-pdufa-6-letter/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136584

Stakeholders are expressing general support for a PDUFA 6 commitment letter released by FDA for comments. The American Medical Informatics Association (AMIA) [says](https://www.regulations.gov/document?D=FDA-2016-N-1895-0007&ref=fdaweb.com) the letter’s references to evidence generation and several recent guidances “signal clear interest by the agency to leverage informatics tools and methodologies to augment regulatory decision-making. We fully support these efforts and believe AMIA members are well-positioned to help FDA understand the nuances of applying data from nontraditional sources to inform drug reviews and surveillance.” The groups says its members are particularly interested in these items in the letter: enhancing use of real-world evidence for use in regulatory decision making; enhancing incorporation of the patient’s voice in drug development and decision making; advancing model-informed drug development; enhancing capacity to support analysis data standards for product development and review; and enhancement and modernization of the FDA drug safety system.

AMIA says it interprets those FDA activities as a “strategy to leverage the digitization of clinical data and the ongoing development of a post-market environment for drug reviews and approvals.” Reflecting on the current state of those domains, it highlights these aspects: 

- biomedical data standards at the intersection of clinical care and research are immature and inconsistently applied;
- policy development on the supplemental use of data for purposes of evaluation and research is needed to ensure consistent accurate interpretation of privacy and human subject protection regulations; and
- ecosystem-wide cooperation and communication is needed to ensure stakeholders understand one another’s values and constraints.

In its comment letter, the National Organization for Rare Disorders (NORD) [says](https://www.regulations.gov/document?D=FDA-2016-N-1895-0039&ref=fdaweb.com) it supports additional resources to implement the FDA breakthrough therapy program. “With the additional funds in the goals letter, we hope the breakthrough therapy pathway can be opened to more orphan therapies for rare inherited disorders,” it says. It also voices support for early consultation on new surrogate endpoints and rare disease drug development advancing development of drug-device and biologic-device combination products, enhancing use of real work evidence in regulatory decision making, and enhancing incorporation of the patient’s voice in drug development and decision making.

Other areas where policy changes should be considered, NORD says, include additional funding for the Office of Orphan Drug Development to reduce review times and expansion of the current Patient Liaison Program to an Office of Patient Affairs.

The Milken Institute’s FasterCures project [says](https://www.regulations.gov/document?D=FDA-2016-N-1895-0040&ref=fdaweb.com) it is very pleased overall with the FDA recommendations and believe the proposals “will continue to enhance and improve the drug review program as a whole.” It provides comments on four areas of enhancement identified in the letter: enhancing incorporation of the patient’s voice, improving agency hiring and retention of review staff, enhancing benefit-risk assessment in regulatory decision making, and enhancing use of real world evidence for regulatory decision making.

Pharmaceutical Research and Manufacturers of America [tells](https://www.regulations.gov/document?D=FDA-2016-N-1895-0038&ref=fdaweb.com) FDA that PDUFA 6 will help ensure the long-term sustainability of the agency’s human drug review program by:

- creating efficiencies that can accelerate the development and availability of new medicines to patients while providing scientific and regulatory predictability that will foster continued biopharmaceutical innovation;
- facilitating the systematic integration of the patient perspective into the development and regulatory review of innovative medicines;
- enhancing FDA access to the tools, processes, and expertise necessary to keep pace with the latest scientific advances in drug development and regulation; and
- helping to ensure that FDA can hire and retain a strong scientific and medical workforce to advance its public health mission.

Finally, the Biotechnology Innovation Organization [says](https://www.regulations.gov/document?D=FDA-2016-N-1895-0023&ref=fdaweb.com) the FDA PDUFA 6 letter covered all five priorities that were important to its members: hearing the patient’s voice; hiring and retaining excellent FDA staff; an emphasis on communication, consistency, flexibility, and timeliness in agency-sponsor interactions; long-term PDUFA financial stability through efficiency, modernized processes, and transparent and data-driven management; and review process enhancements.

AstraZeneca submitted a [letter](https://www.regulations.gov/document?D=FDA-2016-N-1895-0002&ref=fdaweb.com) with specific line-by-line comments.