In the past 20 days, there has been an unprecidented amount of activity from DHHS. It's not all one department/agency either. Strange coincidences? Last minute deals before change of leadership? Don't know but surely our U.S. tax dollars are at hard at work looking at clinical trial related issues.
December 30, OHRP published an FAQ on Quality Improvement activities and their relation to clinical research. http://www.hhs.gov/ohrp/qualityfaq.html
January 5, OHRP posts requests for feedback concerning their website and a potential redesign. http://transparency.cit.nih.gov/ohrp/feedback.cfm
January 7, CMS posts revised clarification on medicare billing on MLN matters, retracting an earlier guidance. http://www.sonnenschein.com/docs/docs_healthcare/RevisedMLNMatterSE08.pdf
January 9, AHRQ posted it's draft report on the extent that third-party reimbursement affects clinical trial enrollment. http://www.ahrq.gov/clinic/ta/paypolicy/index.html
January 13, DHHS's OIG publishes report on FDA's enforcement on Financial Disclosures. http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf
January 15, OHRP amends 45CFR46 by creating "Subpart E" regarding IRB registration. http://edocket.access.gpo.gov/2009/E9-588.htm
January 15, FDA for the first time created regulations requiring IRB registration. http://edocket.access.gpo.gov/2009/E9-682.htm
January 15, FDA posts guidance on reporting of adverse events to IRBs. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0202-gdl.pdf