BN Business News
Business Maps⌕ Search Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 1.11.2004

Draft Guidance for Industry on Pharmacokinetics in Pregnancy-Study Design, Data Analysis, and Impact on Dosing and Labeling

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Industry on Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and Impact on Dosing and Labeling." This guidance discusses agency recommendations on issues to consider when designing and conducting pharmacokinetic (PK) studies in pregnant women and, specifically, on how to assess the influence of pregnancy on the PKs, and where appropriate, the pharmacodynamics (PD) of drugs or biologic products. The goals of this guidance are to recommend a framework for designing and conducting PK studies in pregnant women and stimulate further study and research to assist in rational therapeutics for pregnant patients.

Source: Federal Register — Food and Drug AdministrationOpen original release →
6

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.

Read summary →

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.

Read summary →

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.

Read summary →