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FDA Medical Device Recall Guidance [Process Explained]

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FDA Medical Device Recall Guidance [Process Explained]

This article clarifies guidance for FDA device recalls, defining key terms, outlining regulatory requirements for voluntary and mandatory recalls, and explaining differences between recalls vs enhancements.

Food and Drug Administration Drug approval

The Food and Drug Administration has reversed course and will now consider whether to approve a new flu shot from Moderna that uses mRNA technology. The new development comes a week after the FDA rejected the company's initial application, saying its research design was flawed. Moderna is now seeking full approval for the vaccine's use in adults aged 50 to 64 and what's called accelerated approval for those 65 and older. The company says the FDA set an August deadline for approval. Moderna hopes

The Food and Drug Administration has reversed course and will now consider whether to approve a new flu shot from Moderna that uses mRNA technology. The new development comes a week after the FDA rejected the company's initial application, saying its research design was flawed. Moderna is now seeking full approval for the vaccine's use in adults aged 50 to 64 and what's called accelerated approval for those 65 and older. The company says the FDA set an August deadline for approval. Moderna hopes

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FDA will drop two-study requirement for new drug approvals, aiming to speed access

FDA will drop two-study requirement for new drug approvals, aiming to speed access

First new drug for Alzheimer's in 20 years approved by FDA

First new drug for Alzheimer's in 20 years approved by FDA

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Food and Drug Administration Food safety

Around 250 kg of rasgullas were destroyed by the Food Safety and Drug Administration (FSDA) in Sambhal, Uttar Pradesh, during a pre-festival inspection drive. The action followed an inspection of a local manufacturing unit where officials found unhygienic conditions. Samples were collected and sent for laboratory testing to check for possible adulteration. The unit was reportedly shut, and further action will depend on test results. The drive is part of heightened checks ahead of the festive sea

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The U.S. Food and Drug Administration is removing safety warning labels from hormone replacement therapy products, including vaginal estrogen, used to relieve menopause symptoms. Previously, these medications carried a black box warning stating they could increase the risk for certain cancers, heart attack, and stroke. In a statement on Monday, the FDA said the claims were not supported by current evidence and that the warning has been removed to reflect updated research. Stephanie McNally, MD,

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