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FDA PROPOSES BROAD ISOTOPE CONTROL The Food and Drug Administration is proposing broad new regulatory powers covering rez ctor - produced isotopes used for a wide variety of research and The agency zl ready has authority over drugs if they are related to acc el era - tor - produce ? iso to ges,to naturally - occurring isotopes or cold drug products used in conjunction with an investigation al radioisotope use. cal s derived from reactor Droducts t o be subject to AEC jurisdiction,if they are s>isr;ed for investigation al use in cor.forrnity with SC regulations. This ' 1 gag1' in there gul a toy Trametrork has brought about a nunber of disputes within govern cent,with recent efforts aimed toward a n agreement under which FDA would as suze the same control overall investigation al isotopes as it exercises over other investigation al drugs .-,; (RADIOISOTOPE., REPORT, Sept. 1970). Regulations pro?osed by FDA in late January, 'vlould require that reactor - pro - duced radio ac zl ve drugs3ela je led for uses for which safety and effective - ness nu st be dez on stra tee by formal filing of new drug applications,or through licensing by the U.S. Public Health Service in the case of biologics. The agency also said that such drugs " should not be distributed under inves - tiga tio o al use labeling :.ken they are actually intended for use in medical practice. " k.aij.such dr-:,gs are said to have been distributed indefinitely under this " invest iga tic zal use" exemption, flew drag a ? gli cations are ge2e rally comglex, costly and time-consuming. I n - ciustry sources es tiga tet kc a convent i or alc ev drug nay requires evey y ez rs of5e sting ' acd cert if ic atl on from the tice it is identified.until the time i t is c l ~ zre d? ~ ru se. date of ;he or6er,a ceIi 5rxg agpl l cation or a notice of claimed invest iga - o r an a;zli:zlLDn for liceo se if the drxgk:oxal exer:p-,Liz fora ZSII 8-.;,-, is a Sio los ic. Interested persons have 50 dags from public afi cn of the proposal, January 27, 1971, to sub n it written cor?.zents to Xe a ring Clerk, Department o f Eealtfi, Education acd ' delf are, %z7n 6 - 62, 5600 Fishers Lane, Rockville, Md. 20852.
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TO SUBMIT ADEQUATE EVIDENCE OF SAFETY AXD EFFECTIVENESS FOR USE AS RECOMFENDED IN APPROPRIATE LA BZ LING : SUCH USE MAY INCLUDE, AMONG OTHERS, THE IN THIS TABULATION :U SES Cesiiun 13i... Encsed in needles Interstitid or intmcells. ment of cancer. Do ....... Teirtherapysource. Treatnient of Do....... Labelrd human Castroin:eSinal Do ....... Labeled red blood Cohlt SA or Lobrid cy3noc0- Intestinal absorp Cobslt 60. bnlimin. 1:on sludies. Cobair do..... Tclctliernpysource. Tr urn rn t of UIU Ll oh ii Do.. ..... Eneased in needles Interstitial or inlracells. ment of cancer. ment of pleural or fatty nciilb. meiit of cnncer. Blood volume de