Archive for August 2019
FDA Requests Recall of Florida Compounder’s Sterile Products
Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility on Tuesday, as the agency sought a recall of all sterile products compounded at the facility. Source: Drug Industry Daily
Read MoreChinese OTC Firm Warned for Falling Short on Testing
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release. Source: Drug Industry Daily
Read MoreBaxalta Loses Motion for Patent Infringement Retrial Against Bayer
A federal court in Delaware has denied Baxalta’s request for a new trial in a suit brought by Bayer over patent infringement by Baxalta’s hemophilia A drug Adynovate. Source: Drug Industry Daily
Read MoreFlorida Lays Out Plan to Import Canadian Drugs
Florida has submitted a plan to HHS for how the state will import lower-cost prescription drugs from Canada. Source: Drug Industry Daily
Read MoreWashington Drugmaker Cited for Lacking Quality Unit
The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations. Source: Drug Industry Daily
Read MoreFrance Issues EU’s First Cybersecurity Guidelines
France’s National Agency for Safety of Medicines and Health Products released new cybersecurity recommendations for medical devices designed to minimize the risk of cyber attacks. Source: The GMP Letter
Read MoreCanada Issues New Premarket Requirements for Cybersecurity
Health Canada has issued new guidance on its premarket requirements for medical device cybersecurity. Source: The GMP Letter
Read MoreFDA Warns of Security Holes in Medtronic’s Insulin Pumps
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Source: The GMP Letter
Read More483 Roundup: FDA Cites Five Firms for Complaints, Validations
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Source: The GMP Letter
Read MoreFDA Issues Draft Guidance on Labeling of Combination Products
The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations. Source: The GMP Letter
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