We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
The FDA is planning studies on whether drugmakers are effectively conveying the risks associated with a drug when benefit claims about the drug are made online in character-space-limited communications. Read More
The FDA’s Office of Prescription Drug Promotion is ordering Supernus Pharmaceutical to stop making misleading claims about the use and risks of Oxtellar XR. Read More
An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More