FDA investigators visiting a Vista Pharmaceuticals plant in Nalgonda, India found equipment used to manufacture drugs riddled with holes and corrosion, according to a warning letter issued July 5. Source:…

The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Source: Drug Industry Daily

The FDA has accepted Amicus Therapeutics’ submission of its rare disease drug for review, a reversal from its decision under the Obama administration. Source: Drug Industry Daily

The FDA needs to clearly communicate to drugmakers how the agency will use adverse event data gleaned through the expanded access use process, according to a new GAO report. Source:…

An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Source:…