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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
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
FDA Chief Scientist Jesse Goodman is leaving for Georgetown University and the D.C. Veterans Administration Hospital to serve as a professor and to practice medicine, FDA Commissioner Margaret Hamburg said Thursday. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More
Teva Pharmaceuticals has chosen an agro-chemicals expert as its new CEO. Former Makhteshim Agan Industries (MAI) chief Erez Vigodman takes Teva’s helm Feb. 11, Teva said Thursday. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More