The U.S. Food and Drug Administration recently issued final guidance outlining the agency's enforcement policy regarding the sharing of scientific information with health care providers regarding unapproved uses of approved or cleared medical products.
In a Law360 article, life sciences regulatory and compliance partner Joshua Oyster discussed how certain changes between the draft and final versions of the guidance are likely to be seen as beneficial to drug and medical device companies.
For example, Joshua explained that FDA’s focus on a “scientifically sound” standard for data supporting communications covered under FDA’s enforcement policy, rather than the “scientifically sound and clinically relevant” standard of the draft guidance, will likely give companies more flexibility in their communications under the guidance.
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