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FDA
FDA Quantitative Summary of the Benefits and Risks of Prescription Drugs: A…
The Food and Drug Administration (FDA) recently announced the availability of a draft report entitled “Quantitative Summary of the…
FDA Submits to Congress User Fee Act Recommendations
The U.S. Food and Drug Administration (FDA) last week announced that it had completed its recommendations for three user fee…
FDA: Transmucosal Immediate-release Fentanyl (TIRF) REMS
The Food and Drug Administration (FDA) recently approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the…
FDA Medication Guides – Distribution Requirements and Inclusion in Risk…
The Offices of Regulatory Policy, Medical Policy, Surveillance and Epidemiology, New Drugs, Compliance, and Generic Drugs in the…
FDA Guidance Responding to Unsolicited Request for Off-Label Information…
Recently, the Food and Drug Administration (FDA) released a Guidance for Industry, entitled “Responding to Unsolicited Requests…
FDA the Headache of Developing a Biosimilar Pathway
A recent article from MedPage Today explored a provision in the healthcare reform bill that called on the Food and Drug…
CMS-FDA Breast Cancer and Avastin: FDA Pulls Approval While CMS Pays
Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg announced in a 69-page decision that the agency would…
Policy Updates and Enforcement Developments from FDA’s Medical Products…
A recent conference hosted by the Food and Drug Law Institute looked at the evolving role of technology, particularly in the realm…
In Advance of PDUFA FDA on Record Approval Pace
Every five years the pace of FDA evaluations and approvals increases in advance of PDUFA renewal in congress. This year has…
Sorrell vs. IMS Health: FDA’s Ban on Truthful Off Label Promotion May be…
A recent panel of health lawyers discussed the Supreme Court decision in IMS v. Sorrell and further assessed the impact of the…