A European Medicines Agency report states that 944 API manufacturers were inspected in the first six years of the International Active Pharmaceutical Ingredient Inspection Program. Source: Drug Industry Daily
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Source: Drug Industry Daily
An Ohio judge ordered the Drug Enforcement Administration to turn over more data in multidistrict litigation against opioid manufacturers and distributors. Source: Drug Industry Daily
The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures. Source: Drug Industry Daily
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Source: Drug Industry Daily
A group of hemophilia patients and activists petitioned the FDA to hold a public hearing on court-ordered drug restrictions after an intellectual property suit filed by Shire requested restricted access…
Rep. Keith Ellison (D-Minn.) questioned the appointment of CVS Caremark vice president and former Pfizer executive Daniel Best to oversee HHS drug pricing reforms in a letter to Secretary Alex…
China’s Food and Drug Administration asked for additional feedback on draft guidance covering its unique device identification system. Source: The GMP Letter
The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Source: The GMP Letter
Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA…