CBER director Vinay Prasad overrules the Center’s career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza vaccine.
The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadingly overstates the drug’s benefits and omits important risk information.
CBER director Vinay Prasad overrules the Center’s career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza vaccine.
The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadingly overstates the drug’s benefits and omits important risk information.
A detailed Reuters report looks at instances of surgical adverse events that may be related to artificial technology-enhanced medical devices being used in the procedures.
Politico says some GOP senators expressed frustration with FDA over a lack of apparent progress on its supposed safety review of the abortion drug mifepristone.
