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The FDA plans to standardize electronic drug applications and other regulatory submissions over the next five years and will release a host of guidances in 2014 and 2015 to implement the standardization. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More
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
With the FDA set to tackle a host of new responsibilities, Congress should boost the agency’s fiscal 2014 funding to help it carry out its expanded mission, advocates for the FDA say. Read More
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. 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 and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. 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