The Food and Drug Administration approved on Friday a label change for Pfizer's birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor in the lining of the brain.
Pharmaceutical Technology on MSN
FDA approves meningioma label warning on Pfizer’s contraceptive injection
Depo Provera’s label change comes amidst a flurry of over 2,000 lawsuits from women alleging that the contraceptive caused their meningiomas.
The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...
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