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After several months of the downloads section being
offline,
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FRCP and e-Evidence |
A primer on the December 2006 changes to the Federal Rules for Civil Procedure that affect electronic evidence. |
Utah Medical Decision |
This is the 21 OCT 2005 US Federal Court decision against FDA in the Utah Medical case.In this ruling, the Court affirmed (among other things) that FDA may not adopt "industry standards" as "current" Good Manufacturing Practices (cGMP's) by fiat or Guidance. In order to be an action-able item, the practice must be specifically included in the CFR's. |
US
v. Utah Medical
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This is the "Plaintiff's Brief" or, in layman's terms, the FDA's complaint against Utah Medical. It takes the form of requesting the Court to issue a permanent injunction, ordering Utah Medical to cease manufacturing of regulated medical devices. |
US
v. Utah Medical
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This is the "Defendant's Brief" or, in layman's terms, the Utah Medical answer to FDA's complaint. It takes the form of requesting the Court to deny the FDA request for injunction, and to find the FDA arguments without merit. |
21
CFR Part 11 2005
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This is the 2005 go 'round of the FDA soliciting public comment regarding the cost burden of 21 CFR Part 11.(FDA opens a docket for public comment on 21 CFR Part 11 economic burden every two years or so.) |
21
CFR Part 11 2005
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This is where the FDA reports that there were no public comments in the above announced document, and submits its own estimates for the paperwork burden.In summary, roughly 20-30 hours of labor per company, and (quoting FDA) "...no capital costs or operating and maintenance costs associated with this collection of information."Since there is no public comment, FDA requests OMB approval of the analysis. |
21
CFR Part 11 2005
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And OMB approves the analysis. |
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