Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

The Food and Drug Administration FDA or Agency is announcing an opportunity for public

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration FDA Agency or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review …

Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program

The Food and Drug Administration FDA or Agency is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

Determination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKO

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for SYMDEKO and is publishing this notice of that determination as required by law. FDA …

End Stage Renal Disease Annual Facility Survey Form (CMS-2744)

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms

The Food and Drug Administration FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

The Food and Drug Administration FDA Agency or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review …

AS17-Proposed Rule-Legal Services for Veterans: Legal Assistance for Access to VA Programs Grant Program

The Department of Veterans Affairs VA proposes to amend its regulations to implement a new authority requiring VA to establish a pilot program to assess the feasibility of awarding grants …

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 210934 for Sotagliflozin Oral Tablet

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee the Committee. The general function of the Committee is …

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Cellular Tissue and Gene Therapies Advisory Committee the Committee. The general function of the Committee …

Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format

The Food and Drug Administration FDA Agency or we is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …

Agency Information Collection Activities; Proposals, Submissions, and Approvals

The Centers for Medicare Medicaid Services CMS is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act …