FDA Compliance Article | Quality Digest

FDA: Helping Small Businesses Get Big Results

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Small companies have a significant impact on U.S. made pharmaceuticals

It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.

Five Tips for Medical Device Engineers on FDA Design Controls

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Design controls are a necessary part of your requirements as a medical device developer.

Opening the FDA’s History Vault

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The FDA curates a collection of deceptive and dangerous foods, medicines, and so-called medical products.

Tougher Quality Management Enforcement Possible by FDA

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The FDA will have more funding to do its job—including more inspections of life sciences manufacturers

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

Key Challenges for Risk Management in Medical Device Development

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Risk management is a full life-cycle activity for medical device development

Combination Products Review Program

The FDA Mutual Reliance Initiative

For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern.

Risk Management Programs: What the Latest Wave of HIPAA Fines Means

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management

FDA Warning Letters Target Weak CAPA Programs Globally

Creating a Safety Net for Medical Devices

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