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FDA
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…
FDA: Initiative to Vet Advertising of Newly Approved Products, the Launches…
Recently, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP), which was formerly the Division of…
FDA Seeks Input on Device Classification System
Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective…
FDA REMS to Promote Closer Ties to Healthcare Professionals
A recent article from the Food Drug Law Institute (FDLI) Update Magazine, discussed a recent session entitled “The Impact of…
Senator Kay Hagan Encourages FDA to Consider Faster Approval Pathway for…
A recent article from Bloomberg noted that, “Congressional talks to renew the fees drugmakers pay to fund Food and Drug…