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FDA
FDA to Study Disease Awareness Programs
The Food and Drug Administration (FDA) recently announced that it intends to study whether providing disease awareness information…
FDA Prescription Drug Marketing Regulatory Primer
The Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), held a workshop at the Drug Information…
Biosimilar Price Competition and Innovation Act – Discussions on the…
Now that the Affordable Care Act (ACA) was mostly upheld by the United States Supreme Court, one of the major provisions—the…
CBI 14th Annual Forum on Off-Label Guidelines
In light of the new guidance from the Food and Drug Administration (FDA) and numerous high profile court cases, it is necessary…
FDA Generic Drug User Fee Act Draft Guidance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…