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Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of the Regulatory Affairs Professional Society (RAPS) taking place in Phoenix this week. Read More
President Biden signed an executive order Monday authorizing a new initiative to help grow U.S. biomanufacturing, curtail dependence on foreign suppliers for critical supplies like active pharmaceutical ingredients (APIs) and establish and train a highly skilled workforce. Read More
There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute lower back pain, the company said. Read More
In its 2022 Focus Areas of Regulatory Science report released last week, the FDA adds to its list of regulatory priorities research efforts in oncology and rare disease. Read More
In just six pages of final guidance released today, the FDA lays out exactly when and how sponsors should include real-world data and real-world evidence (RWD/RWE) in applications for investigational and new drugs, as well as biologics licenses. Read More
Drugmakers planning to submit investigational drug, new drug or biologics license applications for pediatric drug studies should conduct clinical pharmacology studies using patients with the disease the drug is intended to treat, according to a new draft guidance released by the FDA today. Read More
Two years after issuing a refuse to file (RTF) letter to Y-mAbs regarding Omblastys (omburtamab), the FDA has agreed to hear data supporting the development of the radioisotope-linked antibody designed to deliver targeted radiation to tough-to-treat pediatric brain tumors. Read More