Senator Ron Johnson (R-WI) launches a congressional investigation into FDA’s recent decisions to reject or delay treatments for rare diseases.
FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting requirements.
Senator Ron Johnson (R-WI) launches a congressional investigation into FDA’s recent decisions to reject or delay treatments for rare diseases.
FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting requirements.
FDA warns India’s Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder System at its Sarasota, FL, manufacturing facility.
