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Juno Pharmaceuticals buys Omega Laboratories

Pharmaceutical Technology

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

Cosmetics 130
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FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

The Pharma Data

Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed Today, the U.S. non-listed food allergens). effective Jan. effective Jan.

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FDA’s Recent Update to the Digital Health Policy Navigator

FDA Law Blog

clinical guidelines); Contextually relevant reference information about a disease or condition; Drug-drug interaction and drug-allergy contraindication notifications to avert adverse drug events; Drug formulary guidelines; Duplicate testing or prescription production prevention notification (e.g.,

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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. By Sophia R. Gaulkin — Last week, the U.S. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., All packaged foods served or sold on transportation carriers (e.g.,

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Consumer health innovation – where passion and science meet

pharmaphorum

After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families. “I I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more.

Allergies 105
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It’s a Cruel Summer – Two New OPDP Untitled Letters

FDA Law Blog

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. Mahomes, spouse to Kansas City Chiefs quarterback, Patrick Mahomes, is the mother of 2 young children with severe food allergies.

Drugs 59