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The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More
The FDA has won a consent decree against a Texas compounder barring the company, Specialty Compounding, from producing and selling sterile drugs until it fixes manufacturing quality deficiencies that led to past reports of bacterial contamination of its products. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
The FDA is warning that Pfizer’s Chantix smoking-cessation aid may cause seizures or, when taken with alcohol, lead to unusual or aggressive behavior. Read More
Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. 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 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