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TXT FDA Orders Labeling Changes for Metformin-containing Drugs [172 Words] [ Price : $8.95]
FDA requires changes to labeled recommendations on metformin-containing medicines for diabetes to expand the drug’s use in certain patients with reduced kidney function.
04/08/2016
 
 
TXT FDA Grants Orphan Drug to Anavex for Dementia [134 Words] [ Price : $8.95]
FDA grants orphan drug designation to Anavex Life Sciences Corp. for Anavex 3-71 for treating frontotemporal dementia.
04/08/2016
 
 
TXT CVM Moves to Rescind Phibro Animal’s Carbadox [137 Words] [ Price : $8.95]
CVM begins an approval rescission action against Phibro Animal Health’s carbadox and its use in treating swine because the drug may leave trace amounts of a carcinogenic residue.
04/08/2016
 
 
TXT FDA Creates Combination Products Policy Council [195 Words] [ Price : $8.95]
FDA creates its first Combination Products Policy Council, a senior-level, agency-wide forum for discussing, resolving, and implementing product and policy issues.
04/08/2016
 
 
TXT FDA Panel Unanimously Backs Intercept’s Obeticholic Acid NDA [224 Words] [ Price : $8.95]
FDA’s Gastrointestinal Drug Advisory Committee unanimously (17 to 0) votesto recommend approval for an Intercept Pharmaceuticals NDA for obeticholic acid for treating primary biliary cirrhosis in combination with ursodeoxycholic acid in adults.
04/08/2016
 
 
TXT Comments Sought on E-Submissions to CVM [53 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on extending Office of Management and Budget approval on submitting information electronically to the Center for Veterinary Medicine.
04/08/2016
 
 
TXT EMA Data Integrity Review of Indian Study Site [110 Words] [ Price : $8.95]
The European Medicines Agency (EMA) starts a review involving approved drugs that relied on studies that were conducted at Alkem Laboratories Ltds in Taloja, India.
04/08/2016
 
 
TXT Many Concerns About Emerging Signal Guidance [790 Words] [ Price : $8.95]
Several stakeholders raise statutory and other substantive concerns about an FDA draft guidance on public communication of emerging medical device signals.
04/07/2016
 
 
TXT FDA Clinical Hold on CARDIO-TTR Study [93 Words] [ Price : $8.95]
FDA places a clinical hold on GlaxoSmithKline’s CARDIO-TTR Phase 3 study.
04/07/2016
 
 
TXT 1st Amendment Losses Draw FDA to ‘Truthful’ Speech: Samp [667 Words] [ Price : $8.95]
Washington Legal Foundation chief counsel Richard Samp says recent First Amendment losses have drawn FDA from its theory of using company speech as evidence they may be distributing a drug for an unapproved use.
04/07/2016
 
 
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