US Enters Consent Decree Against Texas Drug Manufacturer
The United States Enters Consent Decree of Permanent Injunction Sterile Drug Products in Violation of Current Good Manufacturing Practice Requirements On Jan. 8, 2016, U.S. District Judge Sam A....
View ArticlePfizer Hit with False and Misleading Video for Precedex
FDA Issued an Untitled Letter to Pfizer for False or Misleading Video on Precedex FDA sent the following untitled letter, dated 01/14/2016, to Pfizer. NDA 021038 Precedex™ (dexmedetomidine...
View ArticleUS Supreme Court Justice Dies During Vacation in Texas
United States Supreme Court Justice Antonin Scalia Associate Justice Antonin Scalia, was found dead at the age of 79 on a luxury resort hotel on Saturday in West Texas, according to the news. Antonin...
View ArticleFDA Video on the Laser Pointers for Risk of Eye and Skin Injuries
Risk of Eye and Skin Injuries from Hand-held Laser Pointers FDA Safety Communication The Food and Drug Administration (FDA) is reminding consumers about the risk of eye and skin injuries from exposure...
View ArticleFDA Warned A Drug Manufacturer for Data Falsification
The United States Food and Drug Administration (FDA) By Global Compliance Seminar (LinkedIn; Twitter) In a recent warning letter, the FDA has warned the drug manufacturer Emcure (Pharmaceuticals Ltd)....
View ArticleFDA Safety Alert for EOS Lip Balm Products
The United States Food and Drug Administration EOS Lip Balm Products The US FDA has received reports of reactions to certain varieties of EOS Lip Balm from consumers. Celebrity-Endorsed EOS Lip Balm...
View Article2016 February MDRs for Essure
Medical Device Reporting (MDR) The Medical Device Reporting pursuant to the (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report significant medical...
View ArticleBSC Is Recalling Fetch 2 Aspiration Catheter Due to Shaft Breakage
Boston Scientific Corporation (BSC) Is Recalling Fetch 2 Aspiration Catheter Due to Shaft Breakage The Fetch 2 Aspiration Catheter is intended to remove small blood clots from peripheral veins and...
View ArticleFormer FDA Commissioner and Her Husband Sued Over Drug Levaquin
Former FDA commissioner Dr. Margaret Hamburg and Her Husband Mr. Peter Brown Have Been and Other Co-Defendants Over Alleged Wrongdoings In Connection with Drug Levaquin IN THE UNITED STATES DISTRICT...
View ArticleSt Jude Files Suit- St. Jude v. Muddy Waters Consulting LLC and Others
Complaint in the United States Court for the District of Minnesota Case number: CASE 0:16-cv-03002-DWF-BRT St. Jude Medical, Inc. (“St. Jude” or “Plaintiff”) filed suit against Muddy Waters Consulting...
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