 | 1967 - 406 halaman
...ophthalmic solutions, surgical sutures, and surgical dressings sterilized by means of irradiation are regarded as new drugs within the meaning of section 201 (p) of the Federal Food, Drug, and Cosmetic Act. An effective new-drug application pursuant to section 505 of the act is therefore a prerequisite... | |
 | 1958 - 342 halaman
...statement "Caution: Federal law prohibits dispensing without prescription." (2) Such preparations are regarded as new drugs within the meaning of section 201 (p) of the Federal Food, Drug, and Cosmetic Act if their labeling or advertising sponsored by or on behalf of their distributor prescribes, recommends,... | |
 | 1977 - 1080 halaman
...medical acceptability, are not generally recognized as safe and effective for contraception and are new drugs within the meaning of section 201 (p) of the Federal Food. Drug, and Cosmetic Act. A completed and signed "Notice of Claimed Investigatlonal Exemption for a New Drug" (Form FD1571... | |
 | 1998 - 1120 halaman
...product that is la-beled, represented, or promoted for the treatment of bolls is regarded as a new drug within the meaning of section 201' p¡ of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the... | |
 | 1956 - 1164 halaman
...ophthalmic solutions, surgical sutures, and surgical dressings sterilized by means of irradiation are regarded as new drugs within the meaning of section 201 (p) of the Federal Pood, Drug, and Cosmetic Act. An effective new-drug application pursuant to section 505 of the act... | |
 | 1962 - 536 halaman
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 | 1971 - 748 halaman
...not generally recognized by qualified experts as safe and effective for any condition of use and are regarded as new drugs within the meaning of section 201 (p) of the Federal Pood, Drug, and Cosmetic Act. (c) Any food or drug within the Jurisdiction of the Federal Food, Drug,... | |
 | 1965 - 1520 halaman
...the provisions of section 502 (f) (1) and/or section 502 (f) (2) and/or section 502 (j), and may be regarded as new drugs within the meaning of section 201 (p) of the act, unless all the following conditions are met: (1) The dosages prescribed, recommended, or suggested... | |
 | 1959 - 518 halaman
...the provisions of section 502 (f) (1) and/or section 502 (f) (2) and/or section 502 (j), and may be regarded as new drugs within the meaning of section 201 (p) of the act, unless all the following conditions are met: (1) The dosages prescribed, recommended, or suggested... | |
 | 1964 - 1242 halaman
...the provisions of section 502 (f) (1) and/or section 502 (f) (2) and/or section 502 (J), and may be regarded as new drugs within the meaning of section 201 (p) of the act, unless all the following conditions are met: (1) The dosages prescribed, recommended, or suggested... | |
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... are new drugs within the meaning of section 201 (p) of the Federal Food, Drug, and Cosmetic Act. A completed and signed "Notice of Claimed Investigational Exemption for a New Drug... 
