FDA releases its latest batch of Warning Letters that includes Hangzhou Linkeweier Daily Chemicals and DermaPharm A/S.
FDA posts a final guidance entitled Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During th...
CDRH advises industry on steps the Center is taking to prioritize work during the Covid-19 public health emergency.
FDA and Pfizer list four ways in which EpiPen and EpiPen Jr could have delayed injection or fail to properly inject.
To increase U.S. coronavirus supplies, FDA is now providing instructions to manufacturers to speed personal protective equipment and other devices imp...
FDA approves orphan drug status for Gileads antiviral remdesivir that is being tested as a possible Covid-19 treatment.
FDA says there is a risk of transmitting the SARS-CoV-2 virus through fecal microbiota for transplantation and additional safety precautions are neede...
FDA issues an emergency use authorization for Cepheids point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test.