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FDA
FDA Generic Drug User Fee Act Draft Guidance
The Food and Drug Administration (FDA) recently issued a draft guideline for Generic Drug User Fee Amendments (GDUFA) to the…
FDA Goals for the Center for Drug Evaluation and Research CDER for FDASIA
One of the significant provisions in the recently enacted Food and Drug Administration Safety and Innovation Act (FDASIA) was the…
Prescription Drug Shortages: FDA Clarifies Congressional Report
The number of drug shortages has been rising steadily over the last five years, nearly tripling from 61 in 2005 to 178 in 2010. …
FDA Seeks Comments on Transparency and Communication for New Entities
The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the statement of work for an…
FDA: Recently Signed PDUFA 5 Provisions to Address Drug Shortages
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which gives…
FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and…
Last week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). Among the numerous…
FDA Outlines Warning Letters for Promotion of Prescription Pharmaceuticals
An article from the Coalition for Healthcare Communication discussed a recent webinar hosted by the Office of Prescription Drug…
FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for…
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies…
FDA User Fee Acts: Congress Drops Limits on Conflict of Interest Wavers
Over the past year, Congress has been extremely busy putting together User Fee Act legislation that will reauthorize the…
FDA: Risk Evaluation and Mitigation Strategies (REMS) Paper on Program…
The Food and Drug Administration (FDA) recently published an Issue Paper discussing the use of surveys to assess whether a risk…