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FDA

California 94010
Blog: http://www.fda.org
The Web site of the US Food and Drug Administration (http://www.fda.gov) The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices.  FDA is responsible for ... Full Bio
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All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack... by FDA Posted in: Blog Posts in Health Education [Posted 05/18/2013] AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: FDA is alerting health care providers of concerns a ... Read on »
Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance by FDA Posted in: Blog Posts in Health Education [Posted 05/17/2013] AUDIENCE: Pharmacy, Patient, Health Professional ISSUE: Pentec Health, Inc. initiated a limited, voluntary ... Read on »
Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for... by FDA Posted in: Blog Posts in Health Education Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated ... Read on »
Tropical Valley Foods Issues Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark... by FDA Posted in: Blog Posts in Health Education Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy ... Read on »
FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new... by FDA Posted in: Blog Posts in Health Education en Español This update is in follow-up to the FDA Drug Safety Communication: Risk of next-morning impairment after use of inso ... Read on »
Rural King Recalls Deer Corn Because of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring ... Read on »
Summary Information for: VASCADE Vascular Closure System (VCS) by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for VASCADE Vascular Closure System (VCS) (P120016). Read on »
Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the... by FDA Posted in: Blog Posts in Health Education Meeting materials posted for May 21-22, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Read on »
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket... by FDA Posted in: Blog Posts in Health Education This document has the following purposes: (1) develop a common understanding of the statutory criteria for granting expedited review to premarket submissions for medical dev ... Read on »
Summary Information for: cobas® EGFR Mutation Test by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for cobas® EGFR Mutation Test (P120019). Read on »
Consumer Information on: cobas® EGFR Mutation Test - P120019 by FDA Posted in: Blog Posts in Health Education The cobas® EGFR Mutation Test is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in cancer-spre ... Read on »
Federal Register: Center for Devices and Radiological Health Appeals Processes; Guidance for... by FDA Posted in: Blog Posts in Health Education The FDA is announcing the availability of the guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes.' This document describes the processes ... Read on »
Federal Register: Center for Devices and Radiological Health Appeals Processes: Questions and... by FDA Posted in: Blog Posts in Health Education The FDA is announcing the availability of the draft guidance entitled 'Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A. ... Read on »
Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits by FDA Posted in: Blog Posts in Health Education May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components asse ... Read on »
Federal Register: Medical Devices; General Hospital and Personal Use Monitoring Devices;... by FDA Posted in: Blog Posts in Health Education The FDA classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a ... Read on »
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A -... by FDA Posted in: Blog Posts in Health Education This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by sectio ... Read on »
Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and... by FDA Posted in: Blog Posts in Health Education This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. Read on »
FDA's Role in Regulating Safety of GE Foods by FDA Posted in: Blog Posts in Health Education Foods from genetically engineered organisms, also known as biotech foods and referred to by some as food from genetically modified organisms (G ... Read on »
Kcentra (Prothrombin Complex Concentrate (Human)) by FDA Posted in: Blog Posts in Health Education STN: BL 125421/0 Proper Name: Prothrombin Complex Concentrate (Human) Tradename: Kcentra Indication: For urgent reversal of a ... Read on »
Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory... by FDA Posted in: Blog Posts in Health Education Meeting Announcement: July 18, 2013 Dental Products Panel of the Medical Devices Advisory Committee Read on »
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