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Attorneys who work in the biopharmaceutical industry say the landmark $740 billion Inflation Reduction Act (IRA) — passed in August and beginning to go into effect this month to lower drug costs — is chaotic, hard to understand and has the drug industry very nervous. Read More
North American Custom Laboratories earned an FDA warning letter for failing to prove it had corrected manufacturing problems that could have impaired product sterility. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has concluded that its proposed quality management maturity (QMM) scoring system is “too complex,” based on findings from two pilot programs. Read More
At the request of sponsor Biogen, the FDA has extended by three months the new drug application review period for tofersen, an investigational treatment for SOD1 amyotrophic lateral sclerosis — a very rare genetically induced form of the fatal disease. Read More
The FDA will keep in place its regulations on orphan drug exclusivity rather than altering them in response to a pivotal U.S. appeals court ruling. Read More
The most likely cost-effectiveness estimates for the Ninlaro treatment combination is below $38,000 per quality-adjusted life-year, NICE said. Read More
In response to record high demand for ibuprofen oral suspension products, the FDA has issued an immediately-in-effect guidance allowing the products to be compounded in outsourcing facilities for use in hospitals and health systems. Read More
The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations. Read More