Decoding Regulatory Expectations: The Art Of A Successful IND Submission

Companies often underestimate the information required for IND submissions, particularly in a sector that’s as diverse as the mRNA sector. Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with their IND. CureVac’s Ulrike Jägle furthers the discussion, offering a critical best practice she and her colleagues rely upon as well to streamline their regulatory interactions.