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Zdrowie i gospodarka · 18.09.2023

Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Labeling for Biosimilar and Interchangeable Biosimilar Products." This draft guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products. The recommendations for biosimilar and interchangeable biosimilar product labeling in this draft guidance pertain only to the prescribing information, except for certain recommendations pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar and interchangeable biosimilar products. When finalized, this draft guidance will revise and replace the guidance for industry entitled "Labeling for Biosimilar Products."

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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