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Home : Personal Injury : Child Injury : FDA Information

Child Injury - FDA Information

FDA, Defense Department Share Data to Enhance Medical Product Safety Reviews: Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulated products for all Americans.
FDA Statement on Gene Therapy Clinical Trial: On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for the treatment of active inflammatory arthritis.
FDA Approves Orlistat for Over-the-Counter Use: The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults.
Custom Ultrasonics Signs Consent Decree: Custom Ultrasonics, Inc. has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation.
Pediatric Drug Development: Pediatric Drug Development Contents: FDA Amendments Act of 2007 (FDAAA) Best Pharmaceuticals for Children Act (BPCA ) Best Pharmaceuticals for...
Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children: Public Health Advisory Nonprescription Cough and Cold Medicine Use in Children FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be...
FDA Drug Safety Podcasts: Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children - Overview: FDA Drug Safety Podcasts Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children Overview FDA Drug Safety Podcasts Home Podcasts by Date Podcasts by Topic Podcast...
Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children: Public Health Advisory Nonprescription Cough and Cold Medicine Use in Children August 15, 2007 1/2008: Please see the updated...
FDA Public Health Advisory: Edetate Disodium (marketed as Endrate and generic products): FDA Public Health Advisory Edetate Disodium (marketed as Endrate and generic products) This information reflects FDA’s current analysis of data...
PREA Labeling Changes: PREA Labeling Changes The following applications fell within the scope of the Pediatric Research Equity Act (PREA), contained new pediatric information, and were not related to studies...

FDA Drug Safety Podcasts: Nonprescription Cough and Cold Medicine Use in Children - Full Version: FDA Drug Safety Podcasts Nonprescription Cough and Cold Medicine Use in Children Full Version FDA Drug Safety Podcasts Home Podcasts by Date Podcasts by Topic Podcast...
The New Over-the-Counter Medicine Label: Take a Look: The New Over-the-Counter Medicine Label: Take a Look Graphic version in PDF format Always Read the Label Reading the ...
Public Health Advisory: Consumers Should Not Use Triaminic Vapor Patch: FDA Public Health Advisory Consumers Should Not Use Triaminic Vapor Patch This product is not currently...
Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies: Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF version of this document) ...
Office of Drug Safety Annual Report FY 2002: Office of Drug Safety Annual Report FY 2002 April 9, 2004 ...
CDER 2005 Report to the Nation: CDER News Along the Pike September 15, 2006 Volume 12, Issue 1 ...
Labeling Change Request Letter: Labeling Change Request Letter for Antidepressant Medications ...
E2B(R) CLINICAL SAFETY DATA MANAGEMENT:: E2B(R) CLINICAL SAFETY DATA MANAGEMENT: DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS Revision 2 ...
Revlimid (lenalidomide) Information: Questions and Answers on Revlimid (lenalidomide) What is Revlimid used for? ...
Background Information on the Suicidality Classification Project: Background Information on the Suicidality Classification Project What is the Suicidality Classification Project and Why is it Necessary? ...

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