FDA warning news from FierceBiotech
NewsFDA criticizes Aventis for Ketek study failures
Aventis allowed a clinical trial of Ketek to proceed uncorrected despite its own audits that revealed "serious protocol violations and regulatory noncompliance by multiple clinical Read more...
Baraclude given Black Box Warning
The FDA has put a Black Box Warning on Bristol-Myers Squibb's hepatitis B drug Baraclude. A warning letter to doctors said that Baraclude should not be given to HIV/HBV co-infected patients who are Read more...
| Press ReleasesPRESS RELEASE: FDA MedWatch - Desmopressin Acetate FDA MedWatch - Desmopressin Acetate - Product Labeling Updated To Include Important New Information About Severe Hyponatremia And Seizures ROCKVILLE, Md., Dec.4, 2007-- FDA notified healthcare Read more... PRESS RELEASE: FDA Issues Early Communication for Chantix FDA Issues Early Communication for Chantix Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid Read more... PRESS RELEASE: Early Communication About an Ongoing Safety Review Early Communication About an Ongoing Safety Review Cefepime (marketed as Maxipime) This information reflects FDA’s current analysis of available data concerning these drugs. Posting this Read more... PRESS RELEASE: FDA Sends Sanofi Warning Letter for Ketek Study FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more... PRESS RELEASE: FDA Announces Revisions to Labels for Cialis, Levitra and Viagra FDA Announces Revisions to Labels for Cialis, Levitra and Viagra Potential risk of sudden hearing loss with ED drugs to be displayed more prominently The U.S. Food and Drug Administration has Read more... |
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