Cover storyFDA’s Proposed DTC Rule Could End TV Drug Ads
FDA’s Proposed DTC Rule would remove the adequate provision option for broadcast drug ads, requiring full risk information in every spot. See what pharma leaders can do now.
Cover storyFDA’s Proposed DTC Rule would remove the adequate provision option for broadcast drug ads, requiring full risk information in every spot. See what pharma leaders can do now.

Celularity will finish-manufacture Vesalius's Peptual peptide APIs at its New Jersey facility under cGMP, ahead of anticipated FDA compounding rulemaking.

FDA's eCTD v4.0 sample submission program lets sponsors validate technical conformance before official filing, with feedback typically within 30 days.

FDA draft guidance defines drug delivery performance data requirements for combination products across investigational, marketing, and post-market submissions.

FDA activates eCTD v4.0 Forward Compatibility for NDAs, ANDAs, BLAs, and INDs from October 16, 2026, opening migration from v3.2.2.
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