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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
The company will pay for six doses if treatment had been discontinued because the patient still had low platelet counts after four days of combined treatment with Cablivi, plasma exchange and immunosuppressive therapy. Read More
Plainville, Conn.,-based AllerQuest, maker of the sterile PRE-PEN Injection — a drug that tests for penicillin allergy before administering a dose of penicillin — was hit with an 11-observation Form 483 for failure to isolate operators from aseptic filling equipment, poor airflow and other lapses. 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
The FDA wants to annualize COVID-19 vaccination with a bivalent vaccine active against the original Wuhan strain plus two Omicron variants (BA.4 and BA.5). Read More