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FDA Considering Outsourcing Core Functions

Posted in FDA Regulation

As if that wasn’t bad enough, they’re considering outsourcing them to a group with strong ties to the pharmaceutical industry.  Sounds like a bad idea to mw. WASHINGTON (Dow Jones)–The U.S. Food and Drug Administration is considering outsourcing decisions about the effectiveness of antibiotics, according to Rep. Rosa DeLauro (D., Conn.). "It is very troubling… Continue Reading

Another case of the FDA not being on the ball – how many people died because of this sort of lax enforcement?

Posted in FDA Regulation

Please give me one good reason why it should take years for the FDA to ban researchers who commit fraud. WASHINGTON — Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address,… Continue Reading

Is this the beginning of the end of the off-label marketing ban?

Posted in FDA Regulation, Off Label Marketing

If Allergan is successful in challenging this rule, then FDA approval will become meaningless.  Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use.  Some would say that’s the world we already live in… Oct. 2 (Bloomberg)… Continue Reading