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Zdrowie i gospodarka · 9.11.2022

Sameness Evaluations in an Abbreviated New Drug Application-Active Ingredients; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sameness Evaluations in an ANDA--Active Ingredients." This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD).

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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