Federal Register notice: FDA seeks comments on an information collection extension entitled Safety Labeling Changes Implementation of Section 505(o)(...
Federal Register notice: FDA determines the regulatory review period for Newron Pharmaceuticals Xadago (safinamide mesylate).
Federal Register notice: FDA sends to OMB a new information collection entitled Assessment of Combination Product Review Practices.
FDA commissioner Scott Gottlieb says that as part of agency efforts to combat the opioid crisis it has issued a Warning Letter to McKesson for supply ...
FDA Critical Path and Regulatory Science Initiatives director Frank Weichold explains the Centers for Regulatory Science and Innovation program and th...
Allergan applauds an FDA draft guidance with questions and answers on the biosimilar product development process.
Four former FDA CDER and CBER executives join the Parexel regulatory consulting group.
Stakeholders suggest revisions to a draft FDA framework for prescription-drug-use related software.