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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
Intas Pharmaceuticals was hit with a 36-page, 11-observation Form 483 following an inspection of its facility in Ahmedabad, India, that reads like a comedy of errors. Read More
Rep. Frank Pallone, Jr. (D-N.J.) is pressing the FDA and NIH on their efforts to ensure ClinicalTrials.gov reporting requirements are followed, referencing recent findings in a letter to the agency chiefs that show significant sponsor compliance issues. Read More
Now is the time to overhaul drug development’s evidence generation system, wrote FDA Commissioner Robert Califf in the journal Clinical Trials. Read More
In a clear sign that the FDA is raising the bar for accelerated approvals, the agency has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move. Read More
“The company has already instituted additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year,” Merck said. Read More