🧪FDA Determines Patent Extension for ZUNVEYL Drug Product
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZUNVEYL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Announces Public Meeting on Drug User Fee Act and Hiring Assessment
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The topic to be discussed is a hiring and retention assessment which was performed by an independent contractor.
Learn More🚬FDA Proposes Tobacco Retailer Training Program Requirements
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 of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions associated with "Tobacco Retailer Training Programs."
Learn More🏥FDA Notice on Proposed Collection for Investigational Device Exemptions
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 of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with investigational device exemptions.
Learn More🥚FDA Notice on Animal Food and Egg Regulatory Program Standards
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 of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on revisions to the collections of information associated with our Animal Food Regulatory Program Standards and Egg Regulatory Program Standards.
Learn More📦FDA Regulatory Update on Export Lists for Food Products
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 the Paperwork Reduction Act of 1995.
Learn More🧪FDA Guidance on Information Collection for Influenza A Reagents
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 the Paperwork Reduction Act of 1995.
Learn More🦷FDA Guidance on Animal Studies for Dental Bone Grafting Devices
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Animal Studies for Dental Bone Grafting Material Devices--Premarket Notification (510(k)) Submissions." This guidance document provides recommendations for animal study design and animal study information to include to support a 510(k) submission for dental bone grafting material devices. This guidance may help manufacturers comply with some special controls for dental bone grafting material devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions.
Learn More🚭FDA Regulation on Tobacco Sales to Shield Children and Adolescents
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 of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled, "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents."
Learn More🦴FDA Classifies Orthopedic Surgical Instruments as Class II Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of orthopedic manual surgical instrumentation for use with total disc replacement devices. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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