Category Archives: Pharma & Biotech

ANDA

Heed New ANDA Requirements—Or Risk a Swift FDA Rejection

The agency has no tolerance for incomplete or inadequate submissions

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..

Write Effective FDA SOPs

9 Best Practices For Writing SOPs—Since FDA Requires Them But Offers Little Guidance

Compliance tip: Speak plainly and directly to “you”—so employees actually read your procedures

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..

FDA generics drugs

FDA Pushes Generics to Market, Removes Approval Barriers

Trump Promises Lower Prices–Next Steps Remain to Be Seen

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..

FDA Regulatory Compliance

Avoid Failed Regulatory Efforts And FDA Form 483

Find Out Why an Organization-Specific Compliance Program Is So Important

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..

FDA Computer System Audit

New FDA Industry Guidance Focuses on Electronic Records

Recommendations Highlight Mobile Devices and Risk-based Evaluations

This summer the Food and Drug Administration (FDA) posted draft guidance on the use of electronic records for automation analysts, laboratory managers and others who work in quality control and quality assurance in the food safety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..