Newsletter - October 26, 2023
FDA’s New Guidance on Off-Label Information Sharing
FDA’s enforcement policy for the distribution of off-label or unapproved information by manufacturers has come a long way in the last decade; from very conservative to reasonably flexible where companies can share off-label information freely provided they follow some basic rules prohibiting overt promotion using...Read More
FDA Warns Against Directed Blood Donations
Often patients request transfusion of blood donated exclusively from specific individuals, like relatives, friends, or those with specific characteristics (e.g., gender, sexual orientation, vaccination status, or religion). Recently, there has been a surge in directed blood donations where patients wanted blood transfusions...Read More
FDA’s New Guidance on Off-Label Information Sharing
FDA’s enforcement policy for the distribution of off-label or unapproved information by manufacturers has come a long way in the last decade; from very conservative to reasonably flexible where companies can share off-label information freely provided they follow some basic rules prohibiting overt promotion using...Read More
FDA Warns Against Directed Blood Donations
Often patients request transfusion of blood donated exclusively from specific individuals, like relatives, friends, or those with specific characteristics (e.g., gender, sexual orientation, vaccination status, or religion). Recently, there has been a surge in directed blood donations where patients wanted blood transfusions...Read More
