FDA News

Sec. 820.80: Acceptance Activities
The Device Industry’s Silent Problem
An FDAnews Webinar Read More
Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
Bethesda, MD Read More
Dietary Supplement GMP Inspectional Readiness:
A Comprehensive Road Map To 21 CFR 111
An FDAnews Virtual Conference Read More
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Novartis Gets 483 for Batch Quality Control Process Flaws

The method Novartis uses to clear batches at its Suffern, N.Y., facility was deemed inadequate by FDA investigators, resulting in a Form 483.Read More

Experts: Use Traditional Marketing as a Guide for Social Media Policy

Companies drafting a social media policy in anticipation of upcoming FDA guidance should try to follow the same general guidelines used for traditional marketing materials, experts advise.Read More

FDA Warns Chinese Devicemaker, Citing Lack of CAPA Triggers

The FDA has warned GRI Medical & Electronic Technology for corrective and preventive action (CAPA) shortfalls and its handling of nonconforming product.Read More

Biotest Recalls Biologic Drug Due to Particles

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles.Read More

Speech Therapy Devicemakers Warned Over Quality System Shortfalls

The FDA has warned two makers of speech therapy devices for quality system issues, as well as for lacking device approvals or clearances.Read More

Report on EU IVD Regulation Calls for Stricter Controls Over Clinical Trials, Genetic Testing

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.Read More

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Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today. Read More
Surviving an FDA Inspection
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not! Read More