CBER Sees False, Misleading Info in Carticel Sales Materials10/19/2009 CBER’s Office of Compliance and Biologics Quality
says that a sales aid and patient biopsy letters for Genzyme’s Carticel (autologous cultured chondrocytes) overstate
its efficacy and make unsubstantiated comparative claims. A 10/8 notice of violation says that Carticel is derived from autologous cultured chrondocytes harvested from the
patient’s normal, femoral cartilage. It is indicated for repairing symptomatic cartilage defects of the femoral condyle
(medial, lateral, or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a
prior arthroscopic or other surgical repair procedure. ...Read More...
Much More Aggressive FDA Enforcement Seen Coming(10/15/2009) The Obama Administration’s new enforcement
approach at FDA continues to be projected by FDA careerists at industry meetings. “Past performance is not a measure
by which to judge the future,” according to CDRH compliance director Tim Ulatowski. The forum was the Food & Drug
Law Institute’s Enforcement and Litigation Conference, held 10/13 in Washington, DC; the reference was to expectations
for a much more aggressive approach to be taken by FDA in pursuing enforcement actions, as outlined under policies recently
articulated by FDA commissioner Margaret Hamburg. ... Read more ...
FDA Media Access Policy ‘Unconstitutional’ Editor Says(10/6/09) FDA’s media access policies are unconstitutional,
FDA Webview editor Jim Dickinson argues in a 10/6 Citizen Petition which asks commissioner Margaret Hamburg to rectify the situation by promulgating a new policy that would restore prior employee
and media freedoms to interact without Press Office supervision. Dickinson, who authored a commentary on this site the day before that predicted the agency’s growing culture of secrecy would defeat Obama Administration
transparency ambitions, says in the petition that current policy violates both the First and the Fifth Amendments to the U.S.
Constitution. Read more ...
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FDA Plans Second Transparency Public Meeting(10/5/2009) FDA is planning a second public meeting 11/3 to flesh out comments on
how to ensure that information about certain agency activities and decision-making is useful, understandable, and accessible
to the public. Specifically, FDA wants detailed comments on three transparency areas: Early communication about emerging safety issues concerning FDA-regulated products Information disclosure about product applications that are abandoned, i.e., no work is being done or will
be undertaken to have the application approved, or withdrawn by the applicant before approval Agency communication decisions about pending product applications. Read more ...
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