Quality

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“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge. View

Websites selling junk drugs threaten the entire ethical drug business — manufacturers, suppliers, shippers, vendors, caregivers and patients too. It’s up to you to defend yourself. But how? View

In this new report from FDAnews, top authorities in quality management give insight and advice on the features that make a system strong and effective. This collection of essays from five of the drug and device industry’s most knowledgeable practitioners illustrates exactly how to create or update a quality management system that hits all the right notes. View

Once confined to the fringes of FDA regulation, extractables and leachables are now in sharp focus. Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices. View

Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb. View

Drug and biologics makers are facing increased scrutiny of data integrity as an energized FDA deploys new tools to empower inspectors and concerns rise over Forms 483 and warning letters. View

“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

Order the Compliance Confidence DVD learning set and learn strategies on how to prepare for, manage and respond to the inspection process. View

Meet Susan Schniepp. She’ll show you how to avoid warning letters ... maybe forever. The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud. View

Biologics and chemical-based medicines are fundamentally different, nowhere so much as under CMC policy changes set forth recently by the EU. But savvy biologics makers are already seeing a double-barreled opportunity in the EU’s action — avoiding costly compliance errors while boosting sales in the bargain. View

You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how the FDA regulations fit in. View

The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions. View