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Zdrowie i gospodarka · 11.06.2024

Emerging Drug Safety Technology Meetings; Program Announcement

The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or we) is announcing a meeting program, the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide applicants with an approved application and/or other relevant parties supporting industry's pharmacovigilance (PV) activities (e.g., academia, contract research organizations (CROs), pharmacovigilance vendors, software developers) who meet the eligibility and selection criteria for participation with an opportunity to meet with CDER staff to discuss their research, development, and use of Artificial Intelligence (AI) and other emerging technologies in PV. The goals of the meeting program in its initial phase are to facilitate mutual learning and discussion of the pharmaceutical industry's application of these technologies to PV, including efforts to validate and verify relevant models. While the EDSTP is specifically focused on the use of AI in PV for postmarket activities, it is part of CDER's multifaceted approach to enhance mutual learning of where

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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