With new products in the pipeline, new technologies on the horizon, and the hint of coming regulatory shakeups, 2019 promises
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Submitting Abbreviated New Drug Applications (ANDA), especially now, is no straightforward matter. The U.S. Food and Drug Administration (FDA) just
...Continue readingDesign A Cleanroom That Cuts Contamination Risk, Complies With ISO 14644-1/2
From square footage and airlocks to the quantity of HEPA filters and low air returns, there are numerous elements to
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9 Best Practices For Writing SOPs—Since FDA Requires Them But Offers Little Guidance
Almost every Food and Drug Administration (FDA) inspection includes a review of standard operating procedures (SOPs), and adverse agency findings
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FDA Pushes Generics to Market, Removes Approval Barriers
The U.S. Food and Drug Administration (FDA) is putting weight behind its effort to protect public health by encouraging the
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Avoid Failed Regulatory Efforts And FDA Form 483
If your life science organization fails to meet regulatory requirements during a Food and Drug Administration (FDA) audit, you can
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This summer the Food and Drug Administration (FDA) posted draft guidance on the use of electronic records for automation analysts,
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A Firm Line on Data Integrity Can Keep Companies on FDA’s Good Side
“Data integrity” isn’t just something for banks and credit reporting agencies to track – it’s also a big deal for
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Using a Broker to Import in the US? You’re Still Responsible for CBP Forms
When you import any goods or merchandise – including pharmaceuticals and medical devices – into the United States, you are
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Would a Defanged FDA Be Good for the Pharma Industry?
Speculation about how the FDA will change under the Trump administration is top-of-mind for every pharma professional today. Everyone from
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