Tag: Food and Drug Administration (FDA)

Kept in the Dark Regarding Allergens: The FDA Warned You, We...

Why is dark chocolate so problematic regarding allergen cross-contact? The FDA explains, shedding light on a broader problem.

Viaskin Peanut Phase III Trial Falls Short, Still Chance for FDA...

The Viaskin Peanut patch therapy still has 50:50 chance of approval according to research note.

‘No Love’ Nashoba Brook Bakery Owner Responds

John Gates responds to our editorial castigating his company and the media.

FDA Has No Love for Nashoba Brook Bakery. Neither Do We

Dig a little deeper and you'll find that it would be more appropriate for Nashoba to list 'Negligence' as an ingredient.

FDA to Reduce Hurdles for Complex Generic Drug Development

Epinephrine auto-injectors would fall within the category of complex drugs as outlined by the commissioner.

Industry Foundation Awards Grant for Study of Allergen Recalls

FARRP receives grant to investigate undeclared allergens, the leading cause of food recalls in the US.

FDA Approves New Peanut Allergy Claim on Labels

Labels may soon claim that early introduction of peanuts may reduce the risk of infants developing peanut allergy.

FDA Warns Pfizer’s Meridian over Handling of EpiPen Malfunctions

Company has 15 working days to respond to numerous FDA concerns.

FDA Grants Kaleo Priority Review Status for Auvi-Q Designed for Infants...

The new epinephrine auto-injector would feature a lower dose and shorter needle length suitable for smaller children.

Approval of Adamis Emergency Epinephrine Solution Expected Next Month

The market is anticipating FDA approval of a novel method of delivering emergency epinephrine.

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