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Food & Drug Administration - Appendix B: Research

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Expedite access and approval of safe and effective drugs and biologics.

Encourage quality applications and data submissions to review division to ensure timely and efficient pre- and postmarket review.

Conduct meetings with sponsors to discuss drug development plans, expanded access programs, and accelerated approval options. Facilitate scientific review of drugs and biologics by FDA advisory committees.

All persons who may benefit from approved therapeutic agents.

The FDA depends on scientific advisory committees to provide independent expert advice to the agency in its evaluation of regulated products. These committees are composed of representatives from academia, research, government, industry and patient advocates.

Expedite regulatory review of promising products for preventive and therapeutic vaccines.

Expand partnership between FDA and its counterparts from outside organizations involved in vaccine development.

Encourage early consultation with sponsoring companies, develop guidance documents, exchange information, and work with other agencies and international organizations. Facilitate scientific review by FDA advisory committees.

All persons who may benefit from approved preventive and therapeutic vaccines.

The FDA depends on scientific advisory committees to provide independent expert advice to the agency in its evaluation of regulated products. These committees are composed of representatives from academia, research, government, industry, and patient advocates.

Expedite improved test methodologies (such as diagnostic reagents and test kits) for HIV detection, confirmation, and viral load measurement.

Ensure timely and efficient pre- and post-market review.

Encourage early consultation with sponsor and develop guidance documents. Facilitate scientific review of drugs and biologics by FDA advisory committees.

All persons who may benefit from approved test methodologies for HIV detection and measurement.

The FDA depends on scientific advisory committees to provide independent expert advice to the agency in its evaluation of regulated products. These committees are composed of representatives from academia, research, government, industry, and patient advocates.

To ensure the safety and effectiveness of HIV-related medical devices.

Expedited access and approval of safe and effective medical devices.

Encourage quality application and data submissions to ensure timely and efficient pre- and post-market review.

Conduct meetings with sponsors on study design; produce guidance documents. Facilitate scientific review of drugs and biologics by FDA advisory committees.

All persons who may benefit from approved HIV-related medical devices.

The FDA depends on scientific advisory committees to provide independent expert advice to the agency in its evaluation of regulated products. These committees are composed of representatives from academia, research, government, industry, and patient advocates.

Appendix B: Research

NIH #1 - Appendix B: Research

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DoE

AHCPR

DoC

DoD

Defense - Research - Appendices - National AIDS Strategy - ONAP

Defense - Research - Appendices - National AIDS Strategy - ONAP

Defense - Research - Appendices - National AIDS Strategy - ONAP