FDA leaders in oncology want sponsors seeking accelerated approval (AA) for cancer drugs to use new trial designs that will make the whole process more efficient and ultimately safer for…
Six EU countries have successfully turned up the heat on sponsors who haven’t shared the findings of their clinical trials, a new analysis finds. But some member states still appear…
Sally Choe, director of the FDA’s Office of Generic Drugs (OGD), will be stepping down from the agency on Oct. 8, and Susan Rosencrance, director of the Office of Lifecycle…
The FDA reprimanded Jerome Stevens Pharmaceuticals in a Form 483 for inadequate validation studies and other deficiencies observed during an inspection of its Bohemia, N.Y., plant from May 25 to…
Repeated problems with aseptic areas landed India’s global pharmaceutical company Cipla Limited a Form 483, in addition to new quality and computer control issues. Source: Drug Industry Daily
The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Source: Drug Industry Daily
Biogen’s investigational drug for SOD1 amyotrophic lateral sclerosis (ALS), tofersen, has delivered more promising results in an extension study published in the New England Journal of Medicine. Source: Drug Industry…
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted down cancer drugs Copiktra and Pepaxto at its meeting late last week. Source: Drug Industry Daily
In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone…
Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce…