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Zdrowie i gospodarka · 25.06.2010

Determination That DELALUTIN (hydroxyprogesterone caproate) Injection, 125 Milligrams/Milliliter and 250 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that DELALUTIN (hydroxyprogesterone caproate) injection, 125 milligrams (mg)/milliliter (mL) and 250 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydroxyprogesterone caproate injection, 125 mg/mL and 250 mg/mL, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for hydroxyprogesterone caproate, future applicants are advised that they may not be able to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.

Source: Federal Register — Health and Human ServicesOpen 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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