We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
The FDA, showing no signs of easing its advertising and marketing enforcement, has rapped DARA BioSciences for omitting risk information about its cancer drug Soltamox in a sales aid. 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
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