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

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

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

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

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

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

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

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

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

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

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 …

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

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

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 …

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

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

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

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

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 …

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 …

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

Processing Certain Claims for Paymentfor Transportation, Care and Services

This notification informs the public of the Department of Veterans Affairs' VA interpretation of law and regulations regarding timely filing for certain claims for payment for transportation care and services …

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 …

Development of an Enhanced Systematic Process for the Food and Drug Administration’s Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments

The Food and Drug Administration FDA or we is announcing the following public meeting entitled Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food. This …

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

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

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

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