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

Zdrowie i gospodarka · 15.02.2019

Established Conditions; Pilot Program

The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program, to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these. The concept of ECs was first described in the FDA draft guidance for industry entitled "Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products", issued May 2015 and has been further discussed in the International Council for Harmonisation (ICH) draft guidance for industry entitled "Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation", issued May 30, 2018. FDA is implementing this pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (i.e., explicit ECs).

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 →