Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.

Jacqueline O’Shaughnessy takes over as acting chief scientist following Denise Hinton’s move to the surgeon general’s office; Hinton previously had been tapped by acting commissioner Janet Woodcock to make a final decision on the accelerated approval status of Covis' preterm birth prevention drug Makena.

Having got hold of two COPD drugs from Spain's Almirall in 2014, AstraZeneca has passed Eklira and Duaklir onto old partner Covis Pharma as it focuses on more targeted respiratory therapies.

A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.