Regulation of Diethylstilbestrol (DES), 1975: Joint Hearing Before the Subcommittee on Health of the Committee on Labor and Public Welfare and the Subcommittee on Administrative Practice and Procedure...94-1, February 27, 1975 |
From inside the book
Արդյունքներ 41–ի 1-ից 5-ը:
Էջ 20
... package insert , and undoubtedly was discussed in medical meetings . It is my experience that physicians cannot keep up with the volumi- nous medical literature . FDA bulletins are not universally read or received . Package inserts are ...
... package insert , and undoubtedly was discussed in medical meetings . It is my experience that physicians cannot keep up with the volumi- nous medical literature . FDA bulletins are not universally read or received . Package inserts are ...
Էջ 33
... package information and package size are set forth . The notice indicates that only one abbreviated new drug application has X been received . After the Federal Register notice of September 26 , 1973 , Eli Lilly & Co. deleted the 25 ...
... package information and package size are set forth . The notice indicates that only one abbreviated new drug application has X been received . After the Federal Register notice of September 26 , 1973 , Eli Lilly & Co. deleted the 25 ...
Էջ 38
... package insert which is phrased in frank and specific language . I would like to stop here . I have a package of our product , which we intend to submit to you , without the tablets . I would like for the committee to have it and add it ...
... package insert which is phrased in frank and specific language . I would like to stop here . I have a package of our product , which we intend to submit to you , without the tablets . I would like for the committee to have it and add it ...
Էջ 50
... package unit and dispensed as such to the patient by prescription only . Second , the package will contain , in addition to the tablets , a patient leaflet and this leaflet is forthright in stating the potential hazards of the treatment ...
... package unit and dispensed as such to the patient by prescription only . Second , the package will contain , in addition to the tablets , a patient leaflet and this leaflet is forthright in stating the potential hazards of the treatment ...
Էջ 51
... package insert for patient guidance that it has changed or altered or affected the favored or best use of a particular drug ? Dr. SCHMIDT . We have some information from surveys that women read and pay attention to the package insert in ...
... package insert for patient guidance that it has changed or altered or affected the favored or best use of a particular drug ? Dr. SCHMIDT . We have some information from surveys that women read and pay attention to the package insert in ...
Common terms and phrases
25 milligrams adenocarcinoma animal drug animal feed approved Bureau carcinogenic carcinoma cattle cervical Chairman clinical Committee concern contraindicated Cosmetic Act daughters DESMA develop dienestrol diethylstilbestrol doctors dosage form dose Drug Administration drug application drug bulletin Eli Lilly emergency estrogens evidence exposed exposure Federal Food Federal Register female offspring followup Food and Drug going GREENWALD hearing Herbst Hospital human HUTT incest incidence indicated investigations issue KARUSAITIS labeling liver method milligrams misuse morning morning-after pill mothers National Cancer Institute oral contraceptives patient package insert percent physician PILLARELLA postcoital contraceptive pregnancy prenatal prescribed present problem procedures proposed rape victims RAUSCHER recommended reported residues risk safety samples SCHMIDT Secretary SEIFE Senator KENNEDY Senator SCHWEIKER side effects statement stilbestrol Subcommittee synthetic estrogen tablets Tablicaps talking therapy threatened abortion tion treatment tumors vaginal adenosis vaginal cancer women York
Սիրված հատվածներ
Էջ 255 - Union, and ordered to be printed [Strike out all after the enacting clause and insert the part printed In italic] A BILL To amend the Fair Labor Standards Act of 1938 to increase the minimum wage rates under that Act, to expand the coverage of that Act, and for other purposes.
Էջ 212 - A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing.
Էջ 269 - Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and...
Էջ 124 - It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time, the syndrome may not develop Hepatic effects; Elevations of serum transaminase and alkaline phosphatase, usually transient, have been infrequently observed in some patients.
Էջ 259 - Q of chapter 1 is amended by adding at the end 20 thereof the following new item : "Part VIII. Deferred compensation.
Էջ 58 - ... one of the most important as well as one of the most legitimate sources of his power.
Էջ 269 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Էջ 269 - ... no residue of the additive will be found ( by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f ) and (g) ) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal...
Էջ 186 - A statement as to whether the drug is (.or is not) limited in its labeling and by this application to use under the professional supervision of a practitioner licensed by law to administer it.
Էջ 124 - ... irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw...