RF Today | 29 January 2013 | Regulatory Doctor

29 January 2013


Does Advisory Committee Transparency Lead to Better Regulatory Decision Making?29 January 2013
The US Food and Drug Administration (FDA) often courts controversy with its decisions to approve or deny new therapies. In the wake of some high-profile scandals in the past decade, the agency has made its regulatory processes more transparent by opening up its advisory committees to more public input and fewer potential conflicts of interest. But, until now, few have asked a simple question: Are those changes leading to improved regulatory outcomes?[Read More…]

US Regulators Consider Formation of New Advisory Subcommittee to Study ‘Data Liberation’29 January 2013
The US Food and Drug Administration’s (FDA) Science Board—an advisory board focused on the mission and competencies of the agency—will soon meet to start the process of reassessing a landmark 2007 report in which it described FDA as being in a state of decline.[Read More…]

Civil Rights Group Argues for Protection of Prescription Databases29 January 2013
The American Civil Liberties Union (ACLU), a constitutional and legal advocacy group, is filing a lawsuit against the Drug Enforcement Administration (DEA) in light of what it calls a constitutionally dubious encroachment on the prescription drug use records of US citizens.[Read More…]

Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants29 January 2013
At the beginning of 2012, The New York Times made something of a sensational claim: Johnson & Johnson had worked to privately phase out its now-controversial metal-on-metal hip implants in 2009 after US regulators approached the company with concerns about their durability and patient safety. In response to that report, the company indicated that the two events were “unrelated,” but now new and potentially troubling information is emerging from a Los Angeles courtroom shows the recall may be the least of the company’s worries.[Read More…]

EMA in Midst of Website Overhaul, Calls for Industry Assistance29 January 2013
The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to regulators electronically, and—perhaps most importantly—find the regulations and guidance documents they need online instead of in a library or legislative building. But as those layers have built over time, it has become exceedingly difficult for a sponsor to find the exact information they are looking for. Perhaps not for much longer, if the European Medicines Agency’s (EMA) latest project is a success.[Read More…]

via RF Today | 29 January 2013.


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