Speaking at a Financial Times conference, FDA commissioner Stephen Hahn says the agency will follow guidelines it has given to industry for approving ...
FDA issues a guidance on the content and format for some labeling information for breast implants.
FDA releases its latest batch of Warning Letters that include Intrathecal Compounding Specialist and Panacea Biotec.
FDA issues a draft guidance with questions and answers for two International Council for Harmonization guidances.
FDA awards a $5 million grant to two universities to create a Center for Research on Complex Generics.
The HHS Inspector General says REMS are not well suited to quickly address the opioid crisis and makes four recommendations to improve their use.
Former FDA principal deputy commissioner Joshua Sharfstein and two co-authors suggest four ways FDA could recommit to greater transparency in Covid-19...
Federal Register notice: FDA makes available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drugs, Including Biologi...