Attorney Bradley Thompson says an FDA announcement of the faster-than-usual clearance of two Apple products the day before a product promotion meeting...
International Contrast Ultrasound Society petitions FDA urging it to remove boxed warnings from ultrasound contrast agents based on current highly fav...
FDA warns Pharmaceutical Laboratories and Consultants about repeat CGMP violations and other issues in its work as a contract laboratory testing OTC d...
FDA denies a 2009 petition asking it to recall vaccines containing unsafe ingredients.
FDA releases its latest batch of Warning Letters that include ITG-Medev, Jabones Y Productos and Pharmaceutical Laboratories and Consultants.
PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help drug sponsors.
FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.
CBER says it expects to publish 16 guidances under two categories during calendar year 2018.