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Zdrowie i gospodarka · 22.04.2020

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted Under a Biologics License Application, New Drug Application, or Abbreviated New Drug Application; Draft Guidance for Industry and Food and Drug Administration; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA entitled "Technical Considerations for Demonstrating Reliability of Emergency- Use Injectors Submitted under a BLA, NDA or ANDA." For injectable drug or biological products that are intended to treat emergent, life- threatening conditions, it is essential to ensure that the emergency- use injector will reliably deliver the drug or biological product as intended. This is particularly critical for drugs when failure of the injector may prevent adequate delivery of a life-saving drug to a patient. The draft guidance describes the technical considerations for demonstrating reliability of emergency-use injectors under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA).

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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