Category Archives: Pharma & Biotech

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This summer the Food and Drug Administration (FDA) posted draft guidance on the use of electronic records for automation analysts, laboratory managers and others who work in quality control and quality assurance in the food safety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