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TXT Withdraw Distribution of Scientific Info Guide: Public Citizen [304 Words] [ Price : $8.95]
Public Citizen says FDA should withdraw its 6/11 draft guidance on distributing scientific and medical publications because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.
10/22/2014
 
 
TXT FDA Accepts Alkermes NDA for Schizophrenia Injectable [164 Words] [ Price : $8.95]
FDA accepts for filing an Alkermes NDA for aripiprazole lauroxil, an investigational, once-monthly injectable atypical antipsychotic for treating schizophrenia.
10/22/2014
 
 
TXT FDA Panel Backs Expanded Kalydeco Use in Cystic Fibrosis [107 Words] [ Price : $8.95]
FDA advisory committee recommends expanded approval of Vertex Pharmaceutical’s Kalydeco (ivacaftor) in people with cystic fibrosis aged six and older who have a R117H mutation in the cystic fibrosis transmembrane regulatory gene.
10/22/2014
 
 
TXT Drug Repackager Recalls Naproxen Cartons That Contain Ibuprofen [122 Words] [ Price : $8.95]
Greensboro, NC-based Contract Packaging Resources recalls 11,640 boxes of Assured brand naproxen sodium tablets because some cartons actually contain bottles of Ibuprofen due to a packaging error.
10/22/2014
 
 
TXT Hamburg Touts FDA Rare Disease Efforts [342 Words] [ Price : $8.95]
FDA commissioner Margaret Hamburg says agency efforts to encourage development of new treatments for rare diseases are paying off.
10/22/2014
 
 
TXT Recalled Supplements Sell with Banned Ingredients: Study [2788 Words] [ Price : $8.95]
Researchers say that two-thirds of dietary supplements recalled by FDA for containing banned substances still contained those or other substances when purchased six months or more after the recall.
10/22/2014
 
 
TXT Court Says Some False Ad Claims Need FDA Expertise [317 Words] [ Price : $8.95]
A California federal court says some Lanham Act false advertising cases require FDA expertise to resolve.
10/22/2014
 
 
TXT OMB OKs Info on Petitions for Exemption from Preemption [51 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on state petitions for exemption from preemption to the Office of Management and Budget.
10/22/2014
 
 
TXT Guidance on Developing Drugs for Migraine [88 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance for industry entitled Migraine: Developing Drugs for Acute Treatment.
10/22/2014
 
 
TXT Workshop on Sentinel Initiative [138 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 2/5/15: “Seventh Annual Sentinel Initiative Public Workshop.”
10/22/2014
 
 
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