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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Brad C. Dunlap who wrote (374)2/19/1997 11:59:00 AM
From: Richard Belanger   of 1762
 
Brad - I don't think the state vs. federal issue is relevant here. NRC licenses and regulates radioisotope use directly in 21 States; the other 29 ("Agreement States") have entered into agreements with NRC to license/regulate radiosiotope use within their states. Agreement States regulations must consistent with NRC regs. About two-thirds of all radioisotope licenses are in Agreement States. For example, California, New York, Illinois and Texas are examples of Agreement States; Ohio, Pennsylvania, NJ, Michigan are not.

With regard to patient release, NRC rules do not preclude Agreement States from adopting more stringent (but not less stringent) requirements; however, my experience is that in the vast majority of cases like this, they will choose to simply follow the NRC's lead. Indeed, the NRC discussed this rulemaking with Agreement State Managers at two public meetings, and no objections were raised.

By the way, the new NRC rule was developed in response to 3 separate petitions submitted by Dr. Carol Marcus (I believe she is with UCLA Med. Center), the Amercian College of Nuclear Medicine, and the AMA.

Best regards, Rich
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