Submitting Abbreviated New Drug Applications (ANDA), especially now, is no straightforward matter. The U.S. Food and Drug Administration (FDA) just released new Generic Drug User Fee Amendments (GDUFA) guidance and yet ANDA submitters are still encountering plenty of ambiguity—even while the FDA is cracking down More..
From square footage and airlocks to the quantity of HEPA filters and low air returns, there are numerous elements to consider when constructing a cleanroom that complies with ISO 14644-1 standards and ISO 14644-2 standards. But noncompliance isn’t exactly an option, especially when the risk More..
Almost every Food and Drug Administration (FDA) inspection includes a review of standard operating procedures (SOPs), and adverse agency findings often stem from SOP administration issues. Everyone should have good (if not great) SOPs—they are required for all life sciences sector companies. Yet the FDA More..
The U.S. Food and Drug Administration (FDA) is putting weight behind its effort to protect public health by encouraging the prescription of generic drugs. That effort, while good for consumers, is creating tension among the agency, physicians, and creators of medical products which are sometimes More..
If your life science organization fails to meet regulatory requirements during a Food and Drug Administration (FDA) audit, you can expect to receive a Form 483. While some 483 observations are resolved amicably, other cases have serious consequences for the concerned organization— ranging from warning More..
This summer the Food and Drug Administration (FDA) posted draft guidance on the use of electronic records for automation analysts, laboratory managers and others who work in quality control and quality assurance in the food safety industry. The document, “Use of Electronic Records and Electronic More..
“Data integrity” isn’t just something for banks and credit reporting agencies to track – it’s also a big deal for drug makers. The U.S. Food and Drug Administration (FDA) has made data integrity a key part of its Current Good Manufacturing Practice (CGMP) regulations, and More..
When you import any goods or merchandise – including pharmaceuticals and medical devices – into the United States, you are subject to compliance requirements involving the Bureau of Customs and Border Protection (CBP) of the Department of Homeland Security (DHS). According to the CBP, in More..
Speculation about how the FDA will change under the Trump administration is top-of-mind for every pharma professional today. Everyone from regulatory affairs personnel and product safety managers to marketing folks and compliance experts are wondering what’s next. Two of the main issues are how Trump’s More..