Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
1.–5. rezultāts no 63.
7. lappuse
... notices and no- tices of opportunity for hearing to iden- tical , related , and similar drug products . Subpart B - Specific Administrative Rulings and Decisions 310.100 New drug status opinions ; statement of policy . 310.103 New drug ...
... notices and no- tices of opportunity for hearing to iden- tical , related , and similar drug products . Subpart B - Specific Administrative Rulings and Decisions 310.100 New drug status opinions ; statement of policy . 310.103 New drug ...
10. lappuse
... notices . All persons with an interest in a product that is identical , related , or similar to a drug listed in a drug effi- cacy notice or a notice of opportunity for a hearing will be given the same op- portunity as the applicant to ...
... notices . All persons with an interest in a product that is identical , related , or similar to a drug listed in a drug effi- cacy notice or a notice of opportunity for a hearing will be given the same op- portunity as the applicant to ...
11. lappuse
... notices . The Food and Drug Ad- ministration applies the same regu- latory policy to all such products . In many instances a determination can readily be made as to the applicability of a drug efficacy notice by an individ- ual who is ...
... notices . The Food and Drug Ad- ministration applies the same regu- latory policy to all such products . In many instances a determination can readily be made as to the applicability of a drug efficacy notice by an individ- ual who is ...
36. lappuse
... notice was issued on or before August 20 , 1976 , in which case the ex- emption is terminated either upon the subsequent issuance of a nonapprovable notice for the new drug application or on November 20 , 1976 , whichever occurs first ...
... notice was issued on or before August 20 , 1976 , in which case the ex- emption is terminated either upon the subsequent issuance of a nonapprovable notice for the new drug application or on November 20 , 1976 , whichever occurs first ...
37. lappuse
... notice was issued on or before August 20 , 1976 , in which case the exemption is terminated either upon the subsequent issuance of a nonapprovable notice for the new drug application or on Novem- ber 20 , 1976 , whichever occurs first ...
... notice was issued on or before August 20 , 1976 , in which case the exemption is terminated either upon the subsequent issuance of a nonapprovable notice for the new drug application or on Novem- ber 20 , 1976 , whichever occurs first ...
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Bieži izmantoti vārdi un frāzes
abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning