Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.