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

The FDA Law Blog

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. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM

PharmaShots

Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg

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Gabapentin side effects in men

The Checkup by Singlecare

Its also prescribed off-label for other types of nerve pain, diabetic neuropathy, mood disorders, and alcohol use disorder. In fact, its kind of a jack-of-all-trades drug, approved by the Food and Drug Administration (FDA) to treat epilepsy, postherpetic neuralgia, and restless leg syndrome.

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What states use Ozempic the most?

The Checkup by Singlecare

Most healthcare providers will prescribe Ozempic off-label or Wegovy only if weight loss can reduce the risk of a more serious health condition. More than 50% of study participants taking Wegovy reported a 15% reduction in their overall weight and more than 75% of them lost at least 10% of their body weight.

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FDA to quickly review Incyte’s Jakafi in chronic GVHD

pharmaphorum

Jakafi has been approved by the FDA in acute GVHD since 2019 and has been on the US market since 2011 for myelofibrosis and also picked up an indication in polycythemia vera in 2014. GVHD is a life-threatening complication following stem cell transplant to treat multiple myeloma and certain types of leukaemia and lymphoma.

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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. This deserves advance consideration; otherwise, the caregiver may be working without instruction or proper training to deliver essential care. February 2019. Accessed March 12, 2022. Public Health. Caregiving Facts.

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Penicillin allergy delabelling: A multidisciplinary approach for improved patient care

Hospital Pharmacy Europe

In developed countries, between five and 15% patients carry a penicillin allergy label , and patients receive a penicillin allergy label by their third birthday in approximately 75% of cases. However, a large body of evidence suggests upwards of 90% of patients with a penicillin allergy label are not truly allergic.