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FDA Complaint Document

The FDA has posted a complaint document related to enforcement actions. The document, authored by CTP, is available for review. Further details on the specific allegations and parties involved are not provided in the initial posting.

Priority review Enforcement Healthcare
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Draft Labeling for Atomoxetine HCL Solution

The FDA has posted draft labeling for Atomoxetine HCL Solution for public comment. This document outlines proposed changes to the drug's labeling, which will impact manufacturers and potentially healthcare providers.

Priority review Guidance Pharmaceuticals
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Strattera Oral Solution SMPC Posting

The FDA has posted the Summary of Product Characteristics (SMPC) for Strattera oral solution on March 13, 2026. This posting provides updated information regarding the drug's characteristics and usage. It is intended for informational purposes for drug manufacturers and healthcare professionals.

Routine Notice Pharmaceuticals
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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 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 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 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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