The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more
On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more
Draft Guidance on Food Recalls Issued - The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more