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Zdrowie i gospodarka · 10/01/2014

Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia (CABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published March 20, 2009.

Source: Federal Register — Food and Drug AdministrationOpen original release →
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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Crisis Response (PHCR) Cooperative Agreement. The Public Health Crisis Response (PHCR) Cooperative Agreement provides rapid funding to help existing public health programs respond to major public health emergencies and crises.

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Zdrowie i gospodarka · 10/5/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Respiratory Protective Devices--42 CFR 84. The purpose of this data collection is to enable 42 CFR part 84 respirator approval certification activities.

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Zdrowie i gospodarka · 9/28/2026

Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Emergency Preparedness (PHEP) Cooperative Agreement. This request proposes to collect information from the PHEP Cooperative Agreement awardees to document and monitor their performance measure progress and fulfillment.

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