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FDA
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…
FDA Reports Fewer Number of New Drug Shortages
As we have noted over the past several months, drug shortages have been causing severe problems for patients in America. Drug…
Former FDA Commissioner Calls for End of FDA Conflict of Interest Rules
As we noted last month, former Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., wrote an op-ed in the…
FDA: Guidance Drug Safety Information and Communications to the Public
As explained in the Food and Drug Administration’s (FDA) mission statement, it is FDA’s responsibility to (1) promote the public…
FDA: PFUFA – Senate Introduces Bi-Partisan Legislation on Drug…
There has been a tremendous amount of attention surrounding drug shortages in the U.S. over the past several months—and rightly…
FDA: Committee Recommends Exploring Anti-NGF Biologics for Chronic Pain…
In 2011, an Institute of Medicine report found that chronic pain affects 116 million Americans and costs the U.S. as…
FDA: Guidance for Acceptance of Foreign Clinical Studies Not Conducted…
On April 28, 2008, the Food and Drug Administration (FDA) amended its regulations on the acceptance of foreign clinical studies…