📋FDA Notice on Information Collection and Compliance 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 information collection associated with certain Freedom of Information and Privacy Act requests.
Learn More🔍Correction Notice for Tobacco Products Advisory Committee Nominations
The Department of Health and Human Services issued a notice correcting the deadline for nominations for voting members on the Tobacco Products Scientific Advisory Committee. The original date of June 25, 2025, has been amended to August 25, 2025, ensuring accurate timelines for potential nominees.
Learn More🚬FDA Correction Notice on Tobacco Research Development Meetings
The document is a correction to a previous notice by the Department of Health and Human Services concerning meetings with industry and investigators related to the research and development of tobacco products. This correction clarifies the subject line for improved accuracy in communication.
Learn More💊FDA Determines SYNDROS Not Withdrawn, Opens Doors for Generics
The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Learn More💊FDA Draft Guidance on Aluminum Content in Parenteral Nutrition Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations." This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA's recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.
Learn More📋FDA Notice on Proposed Information Collection for 510(k) Reviews
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 the 510(k) Third-Party Review Program.
Learn More🧪FDA Notice
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 implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Learn More🏥FDA Information Collection Activities Announcement - Business Overview
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More📊FDA's Information Collection on Tobacco Campaign Affects Businesses
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 Notice on Approved Information Collections and Business Impact
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More