Draft Guidance for Industry and Food and Drug Administration Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: October 3, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets [...]

Documents the Center for Devices and Radiological Health is Considering for Development (FY12)

<!– –> <!– Page Last Updated: 09/29/2011 –> Page Last Updated: 09/29/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm

PMA Final Decisions for July 2011

<!– –> <!– Page Last Updated: 09/28/2011 –> Page Last Updated: 09/28/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm273626.htm

PMA Final Decisions for August 2011

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Twinrix

<!– –> <!– Page Last Updated: 09/27/2011 –> Page Last Updated: 09/27/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094035.htm

FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryTable   FDA’s Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest [...]

Questions and Answers

On September 26, 2011, FDA informed the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that looked at the risk of blood clots for women [...]

Minutes From Stakeholder Meeting on MDUFA III Reauthorization, August 18, 2011

Stakeholder Meeting on MDUFA III ReauthorizationAugust 18, 2011, 1:45 – 3:35 PMHHS Humphrey Building, Washington, DCRoom 325A Purpose To provide a status update of the ongoing MDUFA III negotiations. Participants Meeting Start Time: 1:45 pm Status Update FDA provided a status update of the ongoing negotiations since the last stakeholder meeting on July 27th. July [...]

Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 9, 2011

FDA – Industry MDUFA III Reauthorization Meeting August 9, 2011, 2:15 – 5:00 pm FDA White Oak Building 1, Silver Spring, MD Room 4101-5 Purpose To discuss potential workload and performance impacts of the Institute of Medicine’s report on 510(k)s and the draftguidance on 510(k) Device Modifications: Deciding When to Submit a 510(k) for a [...]

Stay Informed about Small Business

<!– –> <!– Page Last Updated: 09/20/2011 –> Page Last Updated: 09/20/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm270887.htm