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FDA’s Recent Update to the Digital Health Policy Navigator

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won & Lisa M. medication reconciliations and test reconciliations); Reminders for preventive care or clinician’s orders; and. medication reconciliations and test reconciliations); Reminders for preventive care or clinician’s orders; and.

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FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

FDA Law Blog

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

The Pharma Data

On Tuesday and Thursday , the FDA also announced steps that will lead to tens of millions of additional bottles of infant formula, including specialty infant formula that is in short supply for infants with certain allergies or critical health conditions. Source link: [link].

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FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses

The Pharma Data

. Because the product developer’s application to the FDA did not include data regarding elimination or prevention of food allergies, the FDA’s review process did not evaluate food safety specific to those with AGS, a recently identified type of food allergy to red meat and other products derived from mammals.

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FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

The Pharma Data

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical infant formula is currently in short supply in the U.S. “We

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FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

The Pharma Data

Food allergies and other types of food hypersensitivities affect millions of people in the U.S. The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies. effective Jan.

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FASTER Law Adds Sesame as Major Food Allergen

FDA Law Blog

On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen. By Karin F.R. Moore & Riëtte van Laack —. Then in 2019 Illinois enacted a law that required sesame allergen labeling.