Home » FDA Final Guidance Permits Reprints of Articles on Off-Label Use
FDA Final Guidance Permits Reprints of Articles on Off-Label Use
Drugmakers will be able to distribute journal articles discussing off-label uses of approved products if the articles are separate from promotional information and companies include publications with contrary or differing conclusions, the FDA says in a final guidance. The final version was revised to encourage manufacturers to seek approvals and clearance for new indications and intended uses, according to the FDA’s notice accompanying it.
Drug Industry Daily
Drug Industry Daily
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