⚗️FDA Notice
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 Announces Approved Information Collections Impacting Businesses
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Learn More💉FDA Announces Draft Guidance for Regenerative Medicine Therapies
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry." The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. This draft guidance, when finalized, will supersede the final guidance of the same title dated February 2019.
Learn More🏥Child HCAHPS Survey Database Extension Notice from AHRQ
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the extension, without change, of the currently approved information collection project "Agency for Healthcare Research and Quality's (AHRQ) Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS) Survey Database."
Learn More🏥CMS Proposes Information Collection Activities; Comments Requested
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 of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More📋CMS Proposed Collection of Information under No Surprises Act
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 of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More❌FDA Withdraws Approval of 72 Drug Applications - Business Impact
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 72 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More💰NIH Announces Closed Meetings for Grant Application Evaluations
The Department of Health and Human Services, through the National Institutes of Health, has issued a notice regarding upcoming closed meetings to evaluate grant applications. These meetings will focus on reviewing various health science proposals, potentially impacting research funding and partnerships.
Learn More🏥NIH Meeting on Medical Rehabilitation Research Insights
The National Advisory Board on Medical Rehabilitation Research will hold a hybrid meeting to discuss various topics including reports from the NICHD Director and strategies for outreach to scientific communities. The meeting aims to engage the public and organizations in rehabilitation research, allowing individuals to present comments and insights to influence future initiatives.
Learn More💊FDA Approves Previously Withdrawn NDA for Wellcovorin Tablets
The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.
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