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Should Americans Use Meds Approved In Europe First?
Thursday, July 29th, 2010
Here’s a radical idea: Congress should amend the Food, Drug, and Cosmetic Act to allow Americans to use new meds once these are approved by the European Medicines Authority. Why? “Congress’s grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines,” according to a new report from the Pacific Research Institute, a conservative think tank.
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FDA Advances in Social Media – What’s it Mean for Industry?
Tuesday, July 27th, 2010
Greetings from the 6 th Annual PR & Communications ExL Pharma Summit being held in the headquarters of Pfizer in New York, yesterday and today.
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The FDA As Paper Tiger: China & A Heparin Probe
Thursday, July 22nd, 2010
The FDA may want to get tough with drugmakers that outsource production ( see this ), but how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation. You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 ( back story ), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there ( background ).
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Radiation treatment drug granted fast track status
Thursday, July 22nd, 2010
Cleveland Biolabs’ acute radiation syndrome drug, CBLB502, has received Fast Track status from the FDA. The drug, which would be used to treat patients who have been exposed to radiation from nuclear weapons or dirty bombs, completed Phase I testing in 2008
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FDA Halts A Controversial Avandia Study
Wednesday, July 21st, 2010
Less than a week after an FDA advisory panel voted to allow the controversial Avandia diabetes pill to remain on the market – but with either warnings or restrictions – the agency says new patients should not be enrolled in a long-term, randomized, controlled study known as the TIDE trial, which is designed to compare the drug with the rival Actos pill (see the FDA statement ). The trial has been criticized for being unethical, since it compares one pill with known cardiac risks, GlaxoSmithKline’s Avandia, with a seemingly safer alternative (back story here . To gain some guidance and political cover, FDA commish Margaret Hamburg recently asked an Institute of Medicine committee to explore the ethical issues the FDA faces when requiring a drugmaker to run a randomized clinical trial for an approved drug when a safety issue exists.
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FDA Panel Members Talk About Avandia Conflicts
Wednesday, July 21st, 2010
Twice this week, we have learned that members of the FDA advisory panel convened to review the safety of the Avandia diabetes pill had relationships with drugmakers that had something at stake. One panelist, David Capuzzi, has an ongoing relationship with GlaxoSmithKline as a speaker, although he apparently spoke only once about the diabetes drug ( see here ). And Abraham Thomas has, in the past, given talks about Actos, a rival pill sold by Takeda Pharmaceuticals ( see here ).
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Whither Accelerated Approval? ‘We Have Teeth’
Tuesday, July 20th, 2010
Two years ago, the FDA approved Avastin to combat breast cancer, even though an advisory panel determined that risks such as high blood pressure and death outweighed the benefit of slowing the spread of tumors. The agency, however, acted under its accelerated approval program and the move pumped up sales of a Roche drug that is also used to treat brain, lung and colon tumors
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An Undisclosed Conflict On The FDA Avandia Panel?
Tuesday, July 20th, 2010
When the FDA held a media briefing prior to the controversial advisory panel last week for the Avandia diabetes drug, an agency official was asked whether any conflict of interest waivers were issued for the panel members. Under pressure, you may recall, the agency revised its those rules and now attempts to vet financial holdings or relationships to drugmakers that are provided by panel members ( see this ). In response, Jill Warner, acting associate commissioner for Special Medical Programs, said none were issued.
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FDA Panel Votes To Keep Avandia On The Market
Thursday, July 15th, 2010
And so the vote is in – 20 FDA advisory committee members voted for GlaxoSmithKline’s Avandia diabetes pill to remain on the market, but with either restrictions or labeling changes. By comparison, 12 panel members voted to withdraw the drug. There was one abstention.
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Six Trades on FDA, Clinical Trial Binary Events
Tuesday, July 13th, 2010
Mike Havrilla submits: Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news… BioSante Pharma (NASDAQ: BPAX ) Complete Story
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Business Week – Drug Marketing
Business Week – Pharma Marketing
Cafe Pharma
Clinical Trials.gov
FDA on Twitter
Pharma Live
Pharma Voice