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  • AdvaMed to FDA: Finish Social Media Guidance, Narrow Focus on New Guidance Documents

    The US Food and Drug Administration (FDA) is over-reaching on its planned list of medical device guidance documents, claims a comment notice filed by industry group AdvaMed, which says FDA needs to focus on just seven final guidance documents and the completion of some already promised by the agency. Background Each year, the various centers of FDA publish lists detailing the guidance documents they plan to develop during the coming calendar year, which are often divid...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...
  • FDA Calls for Proposed Industry Labeling Standards

    The US Food and Drug Administration is proposing to study how to best standardize medical device labeling by polling healthcare providers and is calling on industry to generate recommended labeling formats and contents. FDA opened a comment period on the proposed study back in November 2011, and received comments from industry group AdvaMed questioning the utility of the study, the accuracy of the estimated burden, the validity of the methodology and the subject to be ...
  • Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill

    Medical device manufacturers, including their industry representatives, are gaining significant influence on Capitol Hill, reports The Star Tribune . The article notes that the industry, led by industry association AdvaMed, has been working hard with legislators and lobbyists alike to advance initiatives that would reduce their regulatory burdens. Among the recent political developments that are favorable to the industry: A bill to change the US Food and Drug Admini...
  • Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

    As the uproar over the faulty breast implants manufactured by French manufacturer Poly Implant Prothese (PIP) continues to unfold, an unwitting casualty may be the US medical device lobby , which has spent the last several years urging the US Food and Drug Administration (FDA) to loosen regulations to be more in line with EU regulatory standards. The US medical device lobby, led by an association of medical device manufacturers called AdvaMed, has labeled the way the Ce...