Posts relating to “"FDA"” (6368)

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1. FDA May Tighten Rules On Omniscan, A GE MRI Drug

   
   The Huffington Post — Authority 954
   (GE), which contends its product is no riskier than competing imaging drugs. FDA reviewers said GEs drug, Omniscan, had a […] disproportionally high number of reports of the disease compared with its peers. An FDA advisory panel is scheduled to assess on Dec. 8 […] -threatening condition. The disease has no known cure, and the FDA said the two-year mortality risk for NSF patients is more than double that
   4 days ago

2. FDA Questions Safety Of Alcoholic Energy Drinks

   
   The Huffington Post — Authority 954
   beverages are safe, citing complaints that the products can cause risky behavior and injury. The FDA issued a letter Friday to […] . "Today the FDA has listed caffeine only as an ingredient for use in soft drinks," said Deputy Commissioner Dr. Joshua […] Sharfstein. "The agency has not approved caffeine for use in alcoholic beverages." FDA officials stressed they have not reached
   3 weeks ago

3. Washington Legal Foundation Files Brief on Behalf of Patient Organizations …

   
   Policy and Medicine — Authority 420
   First Amendment rights by limiting the authority of the Food and Drug Administration (FDA) to bar drug manufacturers from […] preliminary injunction against FDA enforcement action, WLF argued that FDA has not provided sufficient justification for […] .   “Off-label” uses of a drug or medical device are uses of an FDA-approved product that have not received explicit FDA
   3 days ago

4. LEADEN LIPSTICK

   
   New York Real Estate Lawyers Blog — Authority 447
   Lipstick and Lead: Questions and Answers What is FDAs legal authority over cosmetic safety? Has FDA set limits […] for lead in cosmetics? What are FDAs limits for lead in color additives? Has FDA been aware of concerns about lead […] in lipstick? How has FDA followed up on the latest reports? Is there a safety concern about the lead found by FDA
   4 weeks ago

5. FDA: Convince Us That Caffeinated Alcoholic Beverages Are Safe And Legal …

   
   Consumerist — Authority 803
   The FDA says that companies have 30 days to convince them that caffeinated alcoholic beverages are safe and legal […] , because they dont seem to remember approving them. The FDA says that in order for a substance to be intentionally added to […] food, its particular use has to have been approved by FDA regulation, subject to a prior sanction, or be Generally
   3 weeks ago

6. Feds May Tighten Rules on Omniscan, a GE MRI Drug

   
   ProPublica: Articles and Investigations — Authority 668
   Publica -- marks a setback for GE Healthcare (GE), which contends its product is no riskier than competing imaging drugs. FDA reviewers […] said GEs drug, Omniscan, had a disproportionally high number of reports of the disease compared with its peers. An FDA […] for a lung embolism or other potentially life-threatening condition. The disease has no known cure, and the FDA said the
   4 days ago

7. BioMed Updates: Merck KGaA, BioMarin, Cytori and Theravance

   
   SeekingAlpha.com: Home Page — Authority 634
   (CRL) from the FDA for the telavancin New Drug Application (NDA) for the treatment of nosocomial pneumonia (NP). VIBATIV […] demonstrate the safety and efficacy of telavancin. The FDA also requested further rationale for the pooling of the data from the […] to the FDA. On 10/28/09, THRX and Astellas announced that Astellas Pharma Europe submitted a Marketing Authorization
   6 days ago

8. Dear FDA: Where Are the Public Comments Regarding Regulation of Internet, …

   
   Pharma Marketing Blog — Authority 460
   A public service message from FDA Intern: Not only does FDA Intern want to know where all the comments are […] , I want to know also! Its been over 2 months since the FDA called for comments and three weeks since the public hearing […] available in the public docket. Why is that? I notice that Docket: FDA-2009-N-0294 (Regulation of Tobacco Products; Request
   4 days ago

9. FDA Intern & the Next Steps Toward Pharma Social Media Salvation!

   
   Pharma Marketing Blog — Authority 460
   Now that the big FDA public hearing is over, many people are asking "Whats the next steps?" If you are like me, you […] expect FDA to issue new guidance. My friend John Murray has outlined the usual process FDA goes through when developing […] FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines? There
   2 weeks ago

10. Jim Edwards: FDA Has Only 2 Inspectors Watching Drug Factories in …

    
    popular logistics — Authority 422
    Jim Edwards reported Friday on BNet that the FDA has all of rwo inspectors in China. From FDA Has Only 2 Inspectors […] Watching Drug Factories in China . But the fact that the FDA has just two people to cover a territory 3.7 million square […] producing are safe for Western — or indeed any — patients. An FDA spokesperson said in a statement to BNET: We have two
    7 hours ago