FDA says that while drug shortages have declined since 2011, there still are needs to be addressed to help the agency prevent or mitigate shortages.
FDA publishes a guidance to help IND and NDA sponsors evaluate the drug-drug interaction effects of their investigational drugs on combined oral contr...
FDA accepts for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patients with biliary trac...
FDA approves an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects.
Federal Register notice: FDA determines that Bristol Myers Squibbs Buspar (buspirone HCl) was not withdrawn due to safety or effectiveness reasons.
Federal Register notice: FDA seeks comments on an information collection extension entitled Importation of Prescription Drugs 21 CFR Part 251.
Federal Register notice: FDA renews its Antimicrobial Drugs Advisory Committee for an additional two years.
FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, replacing Sally Choe, who...
