The Securities and Exchange Commission is urging drug makers to include details of FDA 8-K disclosures to make sure shareholder communications are accurate.
Julie Tibbets, partner in the firm’sFood, Drug & Device/FDA Group, says companies need to use care in how they word such disclosures, however.
While openness is important, companies that announce positive FDA feedback can be viewed as conducting inappropriate premarket promotion or commercialization of unapproved products, she says, running afoul of FDA regulations.
Julie Tibbets, partner in the firm’sFood, Drug & Device/FDA Group, says companies need to use care in how they word such disclosures, however.
While openness is important, companies that announce positive FDA feedback can be viewed as conducting inappropriate premarket promotion or commercialization of unapproved products, she says, running afoul of FDA regulations.