Minnesota Drugmaker Cited for Cleaning Deficiencies
The FDA hit Minnesota generic drug manufacturer Upsher Smith Laboratories with a Form 483 over cleaning and batch production violations at its Plymouth facility. Source: Drug Industry Daily
CHMP Recommends 13 New Drugs for Approval, Including Two Orphan Meds
The EMA’s Committee for Medicinal Products for Human Use (CHMP) flagged 13 medicines for approval at its April meeting, including two orphan medications and a biosimilar. Source: Drug Industry Daily
Washington Awards AbbVie Nation’s Second ‘Netflix’ Hep-C Contract
Washington state regulators have awarded AbbVie an exclusive contract to help the state rid itself of Hepatitis C within the next decade—the nation’s second state to adopt a subscription payment…
WHO Issues Urgent Call for New Drugs to Fight Superbugs
Drugmakers and regulators urgently need to create a pipeline of drugs to treat the growing threat of antibiotic-resistant diseases, the World Health Organization says in a new report issued Monday.…
Cincinnati Drugmaker Cited for Quality, Equipment Concerns
The FDA hit Patheon Pharmaceuticals with a Form 483 for equipment and quality violations at its Cincinnati, Ohio facility. Source: Drug Industry Daily
Australia Proposes New Device Classifications to Align With EU Regs
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Source: The GMP Letter
CDRH Warns of Device Shortages Following Sterilizer’s Suspension
CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing…
EC Issues Guidance on Eudamed, Nomenclature System
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and…
FDA Lays Out New Guidance on Anthrax Testing Devices
The FDA released new guidance for devicemakers hoping to sell equipment to test for anthrax and other dangerous bacteria. Source: The GMP Letter
MITA Urges FDA to Clarify Servicing And Remanufacturing Differences
The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Source: The GMP Letter