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FDA
FDA Guidance for Industry Clinical Pharmacogenomics: Premarketing…
Pharmacogenomics (PGx) broadly refers to the study of variations of DNA and RNA characteristics as related to drug response. Drug…
FDA Webinar How to Report Your Local Sales Rep
As we noted last year, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health…
FDA Regulations Doubles Review Time and Quadruples Trial Size for Diabetes…
Cardiovascular safety issues with a number of drugs led the Food and Drug Administration (FDA) in late 2008 to introduce new…
FDA Budget: Trying to Do Everything on Less Money
Recently, the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration…
FDA Medical Device Innovation Initiative
Recently, the Food and Drug Administration (FDA) announced the "Medical Device Innovation Initiative," which proposes actions that…
FDA Guidance: Codevelopment of Two or More Unmarketed Investigational Drugs…
Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and…
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…