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

FDA Law Blog: Biosimilars

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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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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Micromedex

RX Note

In my experience, there are increasingly more off-label uses and dosages included in this resource. NeoFax is one of the most widely used neonatal drug dosing but has been discontinued in print format since June 2012 (The last copy was the 2011 edition ). You may also find extemporaneous formulations within NeoFax.

Dosage 52
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Catabasis craters after giving up on muscular dystrophy lead

pharmaphorum

The PolarisDMD study failed across the board, leaving Catabasis with no choice but to abandon the drug, including an ongoing open-label extension study from an earlier failed trial in the muscle-wasting disease.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. Herbal medicines placed on the market since April 2011 must have either a traditional herbal registration (THR) or a Marketing Authorisation (MA). 2012/1916).