A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situation.
FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredients.
FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three clinical investigations...
Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency post and placed on ad...
FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on classification categor...
Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgic...
Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...
FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, modern approaches to ...
