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FDA
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…
Former FDA Commissioner Calls for Updated Systems and More Education for…
Former Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., recently wrote an op-ed in the Wall Street…
FDA Advisory Committee Vacancies and Interests
Advisory Committees at the Food and Drug Administration (FDA) are receiving a lot of attention lately. Most of the concerns…
Increasing Generic Drug Shortages Linked to Government Price Controls
As we previously noted, the Food and Drug Administration (FDA) recently released guidance to industry regarding the reporting of…
FDA: FDAA DTC Television Ad Pre-Dissemination Review Program
Over the past few years, Congress and media have paid increased attention to direct-to-consumer (DTC) television advertisements…