http://exhibits.library.stonybrook.edu/mfp/files/original/c58fd8cf035ede609e2857bfbc819308.pdf 35b581d2d5cd0bec51912648d96a9683 PDF Text Text w; v—.— n’ "um-m, -—m._~... 1 ”yum. ,4 ... .. um. «mnmgx‘WSJVw‘lJrh~H1-‘ . , . - ~ , "ww-WW-w. 7 - ~. , , , "i-.-“- . ‘7 ~. -mm. " > 4 ‘ .) .w....~..r.. ‘ mm- " 3...... yum: mm“ ~ w-v- '-" ""“""-“‘~“ January 11, 1971 Dr. Marion Finkel Food and Drug Administration 18733 Walker's Choice Rd. Gaithersburg, Maryland 20760 Dear Dr. Finkel: the An FDA announcement in the "Blue Sheet" that your office at new drug evaluation, and the is reviewing guidelines for knowledge that send to you, a Dr. Dorothy Dobbs has left the FDA, prompts me to letter sent to Dr. Dobbs on December 1. "Some weeks ago I received an inquiry which raised my concern. Would I be willing to undertake an EEG study of anti~obesity agent since the PMA guidelines for evaluating such agents includes the phrase: "Consideration may be given to a small EEG sleep Study”? my question is whether the restrictive work ”sleep” should be included. an I\.wr£" “qua...”- . ur-vrv ..-, m... «4 -cmr~.u, mmmww At present, quantitative EEG studies of psychoactive drug; effects have a firm foundation in techniques of EEG analysis, in the classification of drugs, and in the identification of new psychoactive drugs. The literature is most reliable for studies in alert subjects, and it is in such populations that discriminations have been best made. Other data exists for sleep, evoked response and contingent negative variation measures. The literature of the latter twomeasures is sparse. For sleep, there is much data of a descriptive kind and of generally limited value, since samples are small and studies are few. The principal students, Oswald, Itil and Kales, are not agreed as to drug specificity, or the relations of dose or duration. « I'm-e I'Kful "um-wz'rk‘wmwmnw war—W w- um "WV-v "a...“ In view of the possible value of EEG studies in clinical psychopharnacology, may I urge that any FHA—FDA guidelines which may recommend EEG studies, do so without a ”sleep" or "alert" restriction? (Incidentally, such studies may also be useful in bioavailability studies of all psychoactive drug classes, and in classification of anti-psychotic, hallucinogen, stimulant, anti-anxiety and saporific drug doses.)" �Dr. H. Finkel January 11, 1971 —2- I am enclosing a reprint that summarizes the data to 1968, and a more recent report. I would be grateful if you would accept these comments and reports for your deleberations, and I thank you for your consideration. Sincerely yours, Mex Fink, M.D. Professor of Psychiatry MF:kpt enc o � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence to: Finkel, Marion Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-025-1-071 Date A point or period of time associated with an event in the lifecycle of the resource 1971 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York). Language A language of the resource en-US Format The file format, physical medium, or dimensions of the resource application/pdf Publisher An entity responsible for making the resource available Contributor An entity responsible for making contributions to the resource Correspondence