Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing appointments at FDA.
Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest ways for industry to use the information.
Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing appointments at FDA.
Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest ways for industry to use the information.
Sen. Tom Cotton poses questions for attorney general Pam Bondi about the Justice Department’s activities to stop counterfeit drugs and drug ingredients from entering the country.
Novartis asks FDA to restrict ANDAs or 505(b)(2) NDAs citing the company’s Leqvio as the reference-listed drug.
