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

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

Determination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair System

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM and is publishing this notice of that determination …

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

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

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

The Food and Drug Administration FDA or we announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee the Committee. The general function of …

Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution

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; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion

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; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food

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 …

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee the Committee. The general function of the Committee is to provide …

Medicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) (CMS-10912)

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 …

Reauthorization of the Over-The-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments

The Food and Drug Administration FDA the Agency or we is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Over-The-Counter OTC Monograph Drug User Fee …

Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations (CMS-R-71)

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 …

Request for Information: Dental Hygienist Standard of Practice

The Department of Veterans Affairs VA is requesting information to assist in developing a national standard of practice for VA Dental Hygienists. VA seeks comments on various topics to help …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Produce Regulatory Program Standards

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 …

Patient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments

The Food and Drug Administration FDA the Agency or we is announcing the following virtual public workshop entitled Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to …

Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C

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

Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI–C

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

Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

The Food and Drug Administration FDA or Agency is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on among other things …

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 …

Evaluation of Stakeholder Training and Program Support

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 …