Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Informed Consent for In Vitro Diagnostic Device...
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance on Reagents for Detection of Specific Novel Influe...
Two stakeholders respond positively to an FDA guidance on developing a surrogate endpoint table.
AdvaMed praises two FDA draft guidances on blood glucose test systems.
Four senators ask FDA to revise its new biosimilar pathway guidances as they apply to follow-on insulin products.
FDA releases its latest batch of Warning Letters that include Actavis Laboratories, AndaPharm, New Era Naturals and Vilvet Pharmaceuticals.
One month shy of his second full year in the job, FDA commissioner Scott Gottlieb resigns to spend more time with his family in Connecticut.
FDA solicits comments on a proposal to limit some flow cytometer instruments from premarket notification requirements.