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Contract OTC drugmaker Thibiant International allowed unauthorized personnel to access areas of the firm’s buildings and facilities designated as limited access areas, according to an FDA Form 483. Read More
The FDA issued a Form 483 to an Arizona drug compounder for lax monitoring of areas where sterile drugs are produced and for not establishing procedures to prevent contamination of products. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The FDA has warned an Oregon compounder for multiple GMP violations, including poor sterile drug manufacturing practices, using ingredients that aren’t FDA-approved and not receiving valid prescriptions for drugs it was producing. Read More
Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More
In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates. Read More
The FDA last month issued long-awaited guidance for large drug compounding facilities, clarifying the types of companies that must register with the agency, plus providing additional labeling guidance for repackaging activities and adverse event reporting requirements. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The FDA has established a public docket so that compounding pharmacies and others can share their experiences and views regarding the agencies drug compounding regulations. Read More
Astellas Pharma will launch its antifungal drug Cresemba in the coming months, following FDA approval for adults with invasive aspergillosis and invasive mucormycosis — rare, but serious fungal infections most often seen in patients with compromised immune systems. Read More