FDA releases its latest batch of Warning Letters that includes one medical product company Health Solutions Pharmacy.
FDA grants Takeda Pharmaceutical a breakthrough therapy designation for mobocertinib for treating patients with metastatic non-small cell lung cancer ...
FDA discusses potential challenges to bioequivalence studies being conducted for submission with ANDAs during the Covid-19 pandemic.
FDA says its flexibility during the pandemic has led to over 1,500 additional firms registering to produce hand sanitizer.
FDA sends Prefense LLC a Warning Letter for marketing unapproved hand sanitizers for preventing Covid-19.
Federal Register notice: FDA sends to OMB a new information collection entitled Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
The federal government announces that Virginia physician Jeffrey R. Carlson has agreed to pay $1.75 million to resolve allegations that he accepted ki...
FDA tells a Congressional briefing that it is considering tougher requirements on Covid-10 serology (antibody) tests that are on the market without no...