Hospital Conditions of Participation (CoPs) and Supporting Regulations (CMS-R-48)

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 …

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

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ORSERDU and is publishing this

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; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

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

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

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for ORSERDU and is publishing this

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 …

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 …

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 …

Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing

The Food and Drug Administration's FDA or Agency Center for Drug Evaluation and Research CDER is proposing to withdraw approval of two abbreviated new drug applications ANDAs and is announcing …

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 …

Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Provider Survey of Topics Related to Prescription Drug Promotion

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 …

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 …

(CMS-224-14) Federally Qualified Health Center Cost Report Form

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 …

Pre-Market Animal Food Ingredient Review Programs; Request for Comments

The Food and Drug Administration FDA we or Agency is soliciting comments from the public regarding the Food Additive Petition and Generally Recognized as Safe GRAS Notification programs to determine …

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments— Clozapine Risk Evaluation and Mitigation Strategy

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee the Committees. …

Medicare Drug Coverage and Your Rights (CMS-10147)

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 …

Advancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Comments

The Food and Drug Administration FDA the Agency or we is announcing the following public meeting entitled Advancing Rare

Service Level Data Collection for Initial Determinations and Appeals (CMS-10905)

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 …

Conditions of Participation for Critical Access Hospitals (CAH) and Supporting Regulations (CMS-10239)

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 …