FDA

FDA Complaint Document Details

The US Food and Drug Administration (FDA) has posted details regarding a complaint document. The document is available for review, though no specific details about its content or the nature of the complaint are provided in the notice.

FDA Document on Ovarian Cancer Risk Factors

The FDA has released a document concerning risk factors associated with ovarian cancer. This guidance is intended for manufacturers and healthcare providers involved in the pharmaceutical and medical device sectors.

FDA Natural Family Planning Review

The FDA has posted a review concerning Natural Family Planning methods. This document provides updated information and guidance related to these methods.

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.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2191-0001. This document is open for public comment, with a deadline for submissions.

FDA Acknowledgment Letter to North Bay Productions

The FDA's Division of Management and Budget (DMB) issued an acknowledgment letter to North Bay Productions on March 13, 2026. This notice confirms receipt of a submission from the company.

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.

Osteopathic Family Physician Background Material

The FDA has posted background material related to Osteopathic Family Physicians. This notice provides informational content for stakeholders in the healthcare field.

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.

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.