Laboratory Information Bulletins

The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.

Karison Foods & Snacks Inc of Port Washington, NY 11050 is recalling 12 oz containers of ‘PANJIRI’, ‘ALSI PINNI’, ‘PUNJABI PINNI’, ‘BESAN LADDOO’, and ‘NO SUGAR ADDED BESAN LADDOO’ due to undeclared milk allergen

Silvestri Sweets Inc. of Geneva, IL is voluntarily recalling its 5-ounce bags of Choceur branded Holiday Barks because they may contain undeclared allergens.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

Doan’s Bakery of Woodland Hills, CA is recalling White Chocolate Coconut and Carrot Bundt Cakes because they may contain undeclared wheat and milk. People who have an allergy or severe sensitivity to wheat and/or milk run the risk of experiencing a serious or life-threatening reaction if they consum

Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products.