FDA releases a report calling for accelerating the adoption of advanced and smart manufacturing technologies.
Federal Register notice: FDA withdraws a 9/30 notice that announced in error the issuance of a priority review voucher to a rare pediatric disease pro...
Federal Register notice: FDA updates its listing of available guidance documents related to the Covid-19 public health emergency.
Federal Register notice: FDA announces an 11/19 public workshop entitled Best Practices for Development and Application of Disease Progression Models....
Two Hyman, Phelps attorneys explain the orphan drug designation issues facing FDA in light of appeals court decisions against the agency.
Federal Register notice: FDA corrects a notice in the 6/25 Federal Register that announced the approval withdrawal of 36 ANDAs from multiple applicant...
Federal Register notice: FDA seeks comments on an information collection extension entitled Obtaining Information to Understand Challenges and Opportu...
Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 and Fo...