FDA grants Leading BioSciences a fast track designation for LB1148 for treating postoperative gastrointestinal dysfunction associated with pediatric h...
CNBC reports that Operation Warp Speed chief adviser Moncef Slaoui has resigned at the request of the incoming Biden administration.
HHS issues an additional final rule amplifying an earlier good guidance practices rule.
Federal Register notice: FDA sends to OMB an information collection extension for Extralabel Drug Use for Animals 21 CFR 530.
Splitting along ideological lines, the Supreme Court says FDA can enforce a requirement that women seeking a medication abortion must obtain mifeprist...
Two SheppardMullin attorneys outline the contents of an FDA action plan for artificial intelligence/machine learning.
Two Hogan Lovells attorneys describe provisions in an FDA final guidance on the voluntary STeP program for medical devices.
A Florida federal court throws out multidistrict litigation against manufacturers and distributors of generic Zantac.