Part 806 Reports — When to Submit Them and How to Avoid Pitfalls
Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar,…
483 Roundup: FDA Flags Four Firms for GMPs, Quality
The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Source: The GMP Letter
Devicemakers Comment on Machine Learning for SaMD
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device,…
GS1 Issues New Guidelines That Reflect New UDI Requirements
GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards. Source: The GMP Letter
More Notified Bodies Give Up on EU MDR/IVD Certification
The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t…
FDA Data Chief Urges Drugmakers to Sign Up for Quality Metrics Programs
CDER’s associate director for data analysis, Karthik Iyer, urged drugmakers to sign up for the agency’s quality metrics feedback program and the quality metrics site visit program, in a presentation…
483 Roundup: FDA Cites Four Drugmakers for Serious Violations
The FDA hit four drugmakers for a variety of issues, including bug infestations, environmental monitoring and poor record keeping. Source: Drug GMP Report
Australia Updates GMP Clearance Guidance With Processing Times
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications. Source: Drug GMP Report
Aclaris Snags Untitled Letter for Misleading Statements in TV Ad
Aclaris made misleading claims in a TV ad for its seborrheic keratosis treatment Eskata and failed to include details of potential side effects, CDER’s Office of Prescription Drug Promotion said…
FDA Puts Together Supergroup for Track and Trace Pilot
The FDA has asked Merck to team up with IBM, KPMG and Walmart to put together a new pilot program testing whether blockchain can help regulators track and trace prescription…
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