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 …

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 …

Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods

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; 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 …

Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information

The Center for Drug Evaluation and Research CDER and Center for Biologics Evaluation and Research CBER within the Food and Drug Administration FDA or Agency are announcing a request for …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey

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

Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

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; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information

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

The Food and Drug Administration’s Draft Strategy Document on Innovative Manufacturing Technologies

The Food and Drug Administration FDA or Agency is announcing the publication of a draft Strategy Document for public comment outlining specific actions FDA will take during fiscal years 2023-2027 …

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

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

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

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

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

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

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 …

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; Revisions to the Withdrawn or Removed 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 …

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a

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; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs

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 …

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

The Food and Drug Administration FDA announces a forthcoming public advisory committee meeting of the Vaccines and Related

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 215244 for Elamipretide Hydrochloride Injection

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

Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community

The Food and Drug Administration FDA Agency or we is proposing to revoke the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports Medical Device Quality System Audit Reports …