Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling research-use-only (RUO) di...
FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological material, including DNA, ...
FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the latest shake-up at ...
The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advanced manufacturing is...
FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...
Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...
FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.
FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...
