Inspections and Audits

RSS

Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View

To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market. FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know about the FDA’s Biosimilars Action Plan — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. View

The FDA began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation. View

Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research. View

What can you expect from the FDA’s 2018 Compounding Priorities Plan? View

GDP Audit Checklist: Meeting Global Transport and Storage Requirements is written by Simone Ferrante, Head of Quality & Regulatory Affairs for Grieshaber Logistics Group AG, Bad Säckingen. She implemented the company’s GDP/GMP-compliant quality management system. View

CDER, the FDA’s drug-approval arm, pays attention to patient and caregiver input … and so should you. Dr. Khatri shows you what CDER has done, what it wishes to do, and what law and regulation prevent it from doing. View

It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View

What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View

The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it. View

Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View