Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (April 11-12, 2012)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be…

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 8, 2012

FDA – Industry MDUFA III Reauthorization MeetingFebruary 8, 2012, 3:00 pm – 3:45 pmTeleconference PurposeTo discuss MDUFA III reauthorization. Participants Meeting Start Time:  3:00pm Industry responded to some elements of FDA’s proposals regarding fee structure.  Industry agreed with FDA’s December 22, 2011 update to their December 13, 2011 proposal to calculate an annual inflation adjustment…

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 17, 2012

FDA – Industry MDUFA III Reauthorization MeetingFebruary 17, 2012, 2:30 pm – 3:00 pmTeleconference PurposeTo discuss MDUFA III reauthorization. Participants Meeting Start Time: 2:30pm FDA proposed modifications to the draft Commitment Letter and legislative language to address concerns from Industry1.  Commitment LetterFDA revised the Commitment Letter to reflect that FDA will propose to exempt additional…

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 16, 2012

FDA – Industry MDUFA III Reauthorization MeetingFebruary 16, 2012, 4:00 pm – 5:15 pmTeleconference PurposeTo discuss MDUFA III reauthorization. Participants Meeting Start Time: 4:00pm Industry1 provided feedback on FDA’s proposed legislative language.  Industry suggested modification of the definition of an “establishment subject to registration fee.”  Upon discussion, both parties agreed to a revised definition. Industry…

Minutes From Negotiation Meeting on MDUFA III Reauthorization, February 14, 2012

FDA – Industry MDUFA III Reauthorization MeetingFebruary 14, 2012, 8:30 am – 10:15 amTeleconference PurposeTo discuss MDUFA III reauthorization. Participants Meeting Start Time:  8:30am FDA presented a proposal for revised legislative language that reflected Industry’s1 February 10, 2012 proposed fee structure and additional changes.  The definition of an “establishment subject to registration fee” was modified…

FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryLovastatin Dose Limitations References   Infographic About Cholesterol and Statins  Safety Announcement [2-28-2012] The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. These changes were made to provide the public with more information for…

Statin Drugs

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