Re: FDA says off-label communications that are “consistent” with the approved label are acceptable
Very interesting. Thanks for sharing. I guess it comes down to the FDA agreeing with the consensus of the medical community about the relationship of DLB to PDD. I would certainly run any press release, conference presentation or marketing material mentioning DLB by the FDA before releasing. "Examples of unacceptable information, as written in the draft guidance, include use of products to treat different diseases or patients not included in the approval, use of a product through a different route of administration not included in the approval, and use of a product in a different dosage form not included in the approval."