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FDA
FDA Centers for Drug Evaluation and Research: Project Quicker Approval…
This past summer, Congress passed and President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA)…
FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment
Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding…
HHS OIG Report: FDA Lacks Comprehensive Data to Determine Whether Risk…
The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) released a report, which asserts…
PCORI News Plus FDA Suggestions on Comparative Effectiveness Research
The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA…
FDA: Enrichment Strategies to Improve Efficiency of Drug Development
At the end of last year, the Food and Drug Administration (FDA) released a draft guidance document designed to help drug companies…
FDA Updates PDUFA Goals: NDA’s, BLA’s and REMS
The Food and Drug Administration (FDA) recently gave three presentations from the Centers for Drug Evaluation and Research (CDER).…
FDA Center for Drug and Evaluation Research Exclusivity Board, Data…
According to a recent post from the FDA Law Blog, the Food and Drug Administration (FDA) recently announced that the Agency has…
FDA Implementation Timeline and Tracking for the Food and Drug…
In recent post on the Food and Drug Administration’s (FDA) FDA Voice Blog, two members of FDA’s Office of Policy announced a new…
FDA REMS: Mycophenolate Class Wide REMS
Over the past few months, we have seen increased activity at the Food and Drug Administration (FDA) with respect to the issuance…
FDA to Consider Accelerated Approval for Special Medical Use
Over the past few months, the Food and Drug Administration has approved a number of new drugs, including products for obesity and…