Tag: Food and Drug Administration (FDA)

NJ Restaurant

New Law Mandates Food Allergy Handling Info for Restaurants

Restaurants will be required to obtain and post the signs in their kitchens and other appropriate places.
Symjepi

Adamis to Market Pediatric Version of Symjepi Prefilled Epinephrine Syringe

A version of the device suitable for children 33-65 pounds is on the way.
EpiPen

FDA’s New Guidance May Foster More Auto-Injector and Inhaler Competition

Changes will pave way for faster introduction of new products and relaxed rules for substitutability.
DBV Patch Closeup

Positive Safety Results Reported for Viaskin Peanut Phase III Trial

The trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events.
Auvi-Q Measure

FDA Approves Auvi-Q with Lower Dose for Infants and Small Children

New variant also has smaller needle size to prevent hitting bone during administration.
Dark Chocolate

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.
Nashoba Brook Bakery Products

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.
US Food & Drug Administration

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.

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