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FDA Safety Communication: Breast Cancer Screening
Date Issued: June 2, 2011 Audience: Women Health Care Providers Cancer Advocacy Organizations National Association of Attorneys General Medical Specialties: Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology, Nursing, General Practice, Breast Surgery, Acupuncture, Osteopathy, Chiropractic. Product: Thermographic systems use an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on…
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication
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Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication
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FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs–Angiotensin Receptor Blockers (ARBs)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  A list of medications containing an ARB is available here.  In July 2010, FDA communicated its intent to conduct a safety review of ARBs after a published meta-analysis of 5 randomized clinical trials reported a small but statistically significant increase in risk…
Letter To Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami
MEDICAL DEVICE NOTICE TO FOREIGN AND DOMESTIC MEDICAL DEVICE AND COMPONENT ESTABLISHMENTS THAT MAY BE AFFECTED BY THE MARCH 2011 JAPAN EARTHQUAKE AND TSUNAMI June 1, 2011 Japan is a critical participant in the global medical device market. As you know, on March 11, 2011, a massive earthquake and tsunami occurred near the northeastern coast…
Information on Drugs of Abuse Tests (Updated)
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Draft Guidance for Industry and FDA Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: June 1, 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draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 (HFA-305),…
CDRH Learn (New Course Available
Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. Course List Overview of Regulatory Requirements: Medical Devices Quality System Regulation 21 CFR Part 820 Basic Introduction Medical Device Recalls [New! 6/1/2011] CDRH Regulated Software: An Introduction Device Establishment Registration and Listing Overview of the…