FDA issues a Warning Letter to Natural Adventure (Miramar, FL) after reviewing its Web site and social media sites and determining its hand sanitizers...
FDA says A-S Medication Solutions has recalled bottles of extra-strength acetaminophen tablets packaged in Humana health essentials kits because the b...
Public Citizen calls for an immediate HHS Inspector General probe of what it terms FDA collaboration with Biogen on the companys Alzheimers drug aduca...
Three stakeholders comment on an FDA draft guidance on human gene therapy for neurodegenerative diseases.
FDA approves a NuVasive PMA for its Simplify Cervical Artificial Disc for two-level (XXX DELETE XXX) total disc replacement.
Three Sidley Austin attorneys writing for Washington Legal Foundation say a recent 4th Circuit Appeals Court decision increases the burden on plaintif...
FDA approves a Supernus Pharmaceuticals NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder i...
CDER posts a final guidance entitled Development of Abbreviated New Drug Applications During the Covid-19 Pandemic Questions and Answers.