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Regs.gov: Food and Drug Administration

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FDA Proposes Pediatric Labeling Changes for ADHD Drugs

The FDA has issued a proposal to update the pediatric labeling for certain Attention Deficit Hyperactivity Disorder (ADHD) drugs. This consultation seeks public comment on the proposed changes to ensure accurate and up-to-date information for healthcare providers and patients regarding the use of these medications in children.

Priority review Consultation Pharmaceuticals
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FDA Acknowledgment Letter to Irish Multimedia, LLC

The FDA has issued an acknowledgment letter to Irish Multimedia, LLC regarding a submission. The letter confirms receipt of the submission but provides no substantive details on its content or purpose.

Routine Notice Healthcare
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FDA Complaint - Public Comment Period Closed

The FDA has posted a complaint document related to FDA-2026-H-2396-0001. The public comment period for this complaint has now closed. No specific details about the complaint's content or the agency's next steps are available in the provided information.

Routine Consultation Healthcare
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FDA Document Details

The Food and Drug Administration (FDA) has published details for a new document on regulations.gov. This notice provides access to the document and its associated information for interested parties. Further details regarding the document's content are available via the provided URL.

Routine Notice Healthcare
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FDA Natural Family Planning Curricula Background Material

The FDA has posted background material related to Natural Family Planning curricula. This notice provides informational resources for interested parties.

Routine Notice Healthcare
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FDA Complaint for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 13, 2026. The complaint was authored by the CTP and is available for download.

Priority review Consultation Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2387-0001. The document is authored by CTP and is available for download. This indicates a new enforcement action or investigation has been initiated.

Priority review Enforcement Healthcare
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FDA Document - Copyrighted Content

The FDA has posted a document containing copyrighted content, identified by the docket number FDA-2026-P-2640-0004. The content itself is restricted due to copyright. This notice serves to inform the public of the document's availability and its restricted nature.

Routine Notice Healthcare
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FDA Acknowledgment Letter to Special FX Rentals

The FDA's Center for Devices and Radiological Health (CDRH) has issued an acknowledgment letter to Special FX Rentals. This notice confirms receipt of documentation and does not indicate approval or disapproval of any submissions.

Routine Notice Healthcare
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FDA Variance Approval Letter

The FDA has issued a variance approval letter to Richard Lathrop, authored by CDRH. The letter, which contains restricted personally identifiable information, has been redacted and is available for download.

Routine Notice Healthcare

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