The FDA’s Oncology Division has recently taken a hard stance on PI3K inhibitors, a novel class of drugs that inhibit various isoforms of phosphatidylinositol 3-kinase (PI3K) and are approved for treating blood cancers. Recent actions by the FDA, including withdrawing some approved indications, indicate that they will likely be seeking a higher bar for new…
As Pfizer, Moderna, and other pharma companies prepare to seek emergency authorization for their SARS-CoV-2 vaccines, the FDA has laid out a roadmap designed to ensure appropriate scientific rigor and help engender public trust. That plan was the subject of a special meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on October…
One of the fundamental responsibilities of the US Food and Drug Administration (FDA) is to approve effective medicines for people who need them, while upholding high standards for safety. That mission also demands that the FDA work efficiently and not delay approval of life-saving medical advances. Today, the FDA is reviewing applications for approval of…
The US Food and Drug Administration (FDA) review of drugs, although guided by broad standards, remains individualized. Each drug or drug class faces unique challenges during the FDA review phase – thus no two reviews are exactly the same. Each review division within the FDA has its own approach, and evaluations often differ among the…
