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Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More
Negotiators overseeing a civil suit related to last year’s nationwide outbreak of fungal meningitis say they have reached a tentative settlement with the Massachusetts compounder linked to the outbreak that could see victims and creditors receive more than $100 million. Read More
India’s Parliamentary Standing Committee on Health and Family Welfare is taking the next step in its effort to regulate the more than 5,000 unapproved fixed dose combination (FDC) products on the market in the country, calling for recommendations from technical experts. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
The FDA has denied Éclat Pharmaceuticals’ unorthodox request for the agency to shut down competitors the company says are making unapproved versions of its medicine. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More