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18,May,2012 | |||
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MedWatch
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death (+Rss-feeds-talk) Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First ... (+Rss-feeds-talk) Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Co... (+Rss-feeds-talk) Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies (+Rss-feeds-talk) Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians (+Rss-feeds-talk) Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor D... (+Rss-feeds-talk) X-Rock: Recall - Undeclared Drug Ingredient (+Rss-feeds-talk) Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall –... (+Rss-feeds-talk) Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal... (+Rss-feeds-talk)
PressReleases
FDA approves generic versions of blood thinner Plavix (+Rss-feeds-talk) FDA expands use for FilmArray Respiratory Panel (+Rss-feeds-talk) FDA issues alert on potential dangers of unproven treatment for multiple sclerosis (+Rss-feeds-talk) FDA proposal aims to help reduce unnecessary radiation exposure for children (+Rss-feeds-talk) FDA issues final rule on sterility testing of biological products (+Rss-feeds-talk) FDA permits marketing of a new device for abdominal surgery (+Rss-feeds-talk) FDA approves new orphan drug to treat a form of Gaucher disease (+Rss-feeds-talk) FDA approves new antibacterial treatment for plague (+Rss-feeds-talk) FDA challenges marketing of DMAA products for lack of safety evidence (+Rss-feeds-talk)
FoodSafety
Bakery El Monte Sinai Corp Announces Allergy Alert on Undeclared Eggs in Rainbow Cake (+Rss-feeds-talk) Cargill Animal Nutrition Conducts Regional Recall of Select Animal Feed Products (+Rss-feeds-talk) Nestlé Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat Food Due to A Low Level of... (+Rss-feeds-talk) Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California (+Rss-feeds-talk) Jonlly Fruits Inc. Issues Allergy Alert On Undeclared Allergens In Several Products (+Rss-feeds-talk) Jonlly Fruits Inc. Alerta De Alergia Por No Decrarar Alergenos En El Producto (+Rss-feeds-talk) Moon Fishery (India) Pvt. Ltd. Recalls Its "Tuna Strips" Product Of India "AA" O... (+Rss-feeds-talk) Solid Gold Health Products for Pets, Inc. Recalls Dog Food Because of Possible Salmonella Health Ris... (+Rss-feeds-talk) Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be cont... (+Rss-feeds-talk)
Biologics
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Biologic Product Shortages (+Rss-feeds-talk) Complete List of Currently Approved NDA and ANDA Application Submissions (+Rss-feeds-talk) Complete List of Currently Approved Premarket Approvals (PMAs) (+Rss-feeds-talk) Complete List of Substantially Equivalent 510(k) Device Applications (+Rss-feeds-talk) Jobs at the Center for Biologics Evaluation and Research (CBER) (+Rss-feeds-talk) -
Cord Blood Banking Information for Consumers (+Rss-feeds-talk) Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (+Rss-feeds-talk) -
List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f) (+Rss-feeds-talk) Influenza Virus Vaccine for the 2011 - 2012 Season (+Rss-feeds-talk)
Recalls
Bakery El Monte Sinai Corp Announces Allergy Alert on Undeclared Eggs in Rainbow Cake (+Rss-feeds-talk) Hospira Announces A Nationwide Voluntary Recall Of One Lot Of Hydromorphone Hydrochloride Injection ... (+Rss-feeds-talk) Nestlé Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat Food Due to A Low Level of... (+Rss-feeds-talk) Correction to Date Code in Natural Balance Pet Foods’ Voluntary Recall Dated May 4, 2012 Due ... (+Rss-feeds-talk) Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California (+Rss-feeds-talk) Jonlly Fruits Inc. Alerta De Alergia Por No Decrarar Alergenos En El Producto (+Rss-feeds-talk) Jonlly Fruits Inc. Issues Allergy Alert On Undeclared Allergens In Several Products (+Rss-feeds-talk) Moon Fishery (India) Pvt. Ltd. Recalls Its "Tuna Strips" Product Of India "AA" O... (+Rss-feeds-talk) Solid Gold Health Products for Pets, Inc. Recalls Dog Food Because of Possible Salmonella Health Ris... (+Rss-feeds-talk)
Consumers
May 21 Webinar: Steps to Addressing Health Disparities (+Rss-feeds-talk) FDA's MedWatch Safety Alerts: April 2012 (+Rss-feeds-talk) FDA Unit Mobilizes for Emergency Response (+Rss-feeds-talk) Consumer Update Analytics (+Rss-feeds-talk) It's a Small World, After All (+Rss-feeds-talk) FDA Continues Dialogue on 'Nano' Regulation (+Rss-feeds-talk) Fentanyl Patch Can Be Deadly to Children (+Rss-feeds-talk) MedWatch Safety Alerts: March 2012 (+Rss-feeds-talk) FDA's MedWatch Safety Alerts: February 2012 (+Rss-feeds-talk)
Drugs
New and Generic Drug Approvals (+Rss-feeds-talk) Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad ... (+Rss-feeds-talk) Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreati... (+Rss-feeds-talk) -
Newly Added Guidance Documents (+Rss-feeds-talk) Current Drug Shortages (+Rss-feeds-talk) Drugs to be Discontinued (+Rss-feeds-talk) Generic Drugs: Information for Industry (+Rss-feeds-talk) Medication Guides (+Rss-feeds-talk) FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of mult... (+Rss-feeds-talk)
cfTopic
Requesting Speakers from CDRH (+Rss-feeds-talk) Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12) (+Rss-feeds-talk) Federal Register: Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comme... (+Rss-feeds-talk) Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Info... (+Rss-feeds-talk) FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis... (+Rss-feeds-talk) Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging (+Rss-feeds-talk) Public Workshop - Device Improvements for Pediatric X-ray Imaging, July 16, 2012 (+Rss-feeds-talk) Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray... (+Rss-feeds-talk) Pediatric X-ray Imaging (+Rss-feeds-talk)