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FDA
FDA Guidance for Industry on Medication Guides
The Food and Drug Administration (FDA) recently published Guidance for Industry on Medication Guides, entitled “Distribution…
HHS-OIG: CMS-FDA Drug Registration and Listing Systems In Need of Update
The Centers for Medicare and Medicaid (CMS) is America’s largest healthcare payer, covering the costs for hospital and physician…
FDA Proposes Generic Drug User Fee
Over the past several months, the Food and Drug Administration (FDA) has experienced a significant backlog of generic drug…
Coalition of Epilepsy Physicians Calls for Freedom of Expression for Non…
Academic neurologists are educators as well as physicians. As educators, academic neurologists, like many physicians who are…
NEJM The Private Sector Discoveries Account for 79–90% of…
The discovery and development of new drugs, medicines, and vaccines to solve unmet medical needs is an extremely long and…
FDA to Expedite Medical Device Approval
This week, the Food and Drug Administration (FDA) announced a new plan that would speed up the approval of innovative medical…
Shortage of Injection Treatments Looms over ACA
As the Obama Administration and federal agencies begin preparing for implementation of key provisions of the Affordable Care Act…
Risk Evaluation and Mitigation Strategies (REMS) Summary
According to a recent assessment by the Tufts Center for the Study of Drug Development (CSDD), “drug developers, healthcare…
FDA Boot Camp — Hooah
As the regulatory landscape for pharmaceutical and medical device companies continues to rapidly change, and as key provisions of…
FDA Seeks Input on Transparency Initiative
In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help…