Safety AnnouncementAdditional Information for Patients with CKDAdditional Information for Healthcare Professionals who treat Patients with CKDTable of Key TrialsReferences  Safety Announcement [6-24-2011] Normal 0 false false false MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:”Table Normal”; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:””; mso-padding-alt:0pt 5.4pt 0pt 5.4pt; mso-para-margin:0pt; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:”Times New Roman”; mso-ansi-language: mso-fareast-language: mso-bidi-language:}…
Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication
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FDA Update on the Safety of Silicone Gel-Filled Breast Implants (PDF)
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Booklet
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Anaplastic Large Cell Lymphoma (ALCL)
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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: June 22, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management…
Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 1, 2011
FDA – Industry MDUFA III Reauthorization MeetingJune 1, 2011, 10:30 – 5:00 pmFDA White Oak Building 1, Silver Spring, MDRoom 4101-4105 Purpose To discuss Industry’s proposals for the next reauthorization, as well as present data on workload issues and discuss additional FDA proposals. ParticipantsFDA Industry Meeting Start Time:  10:30 amIndustry Presentations ACLA discussed a proposal…
Class I Medical Device Recall: Roche Diagnostics Operations, ACCU-CHEK Performa Strip
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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: June 22, 2011 Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management…
Information on Artificial Pancreas Systems
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