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
6.–10. rezultāts no 100.
99. lappuse
... ANTIBIOTIC DRUG Sec . Subpart A - General Provisions 314.1 Scope of this part . 314.2 Purpose . 314.3 314.50 314.52 Definitions . Subpart B - Applications Content and format of an application . Notice of certification of invalidity or ...
... ANTIBIOTIC DRUG Sec . Subpart A - General Provisions 314.1 Scope of this part . 314.2 Purpose . 314.3 314.50 314.52 Definitions . Subpart B - Applications Content and format of an application . Notice of certification of invalidity or ...
100. lappuse
... antibiotic application and receiv- ing an abbreviated new drug application . 314.102 Communications between FDA and applicants . 314.103 Dispute resolution . 314.104 Drugs with potential for abuse . 314.105 Approval of an application ...
... antibiotic application and receiv- ing an abbreviated new drug application . 314.102 Communications between FDA and applicants . 314.103 Dispute resolution . 314.104 Drugs with potential for abuse . 314.105 Approval of an application ...
136. lappuse
... antibiotic application . For applications submitted under sec- tion 507 of the act , the applicant shall submit a complete archival copy of the abbreviated application that contains the information described under §314.50 ( a ) ( 1 ) ...
... antibiotic application . For applications submitted under sec- tion 507 of the act , the applicant shall submit a complete archival copy of the abbreviated application that contains the information described under §314.50 ( a ) ( 1 ) ...
139. lappuse
... antibiotic application . The applicant shall comply with the provisions of § 314.60 . [ 57 FR 17983 , Apr. 28 , 1992 , as amended at 58 FR 47352 , Sept. 8 , 1993 ] § 314.97 Supplements and other abbre- changes to an approved viated ...
... antibiotic application . The applicant shall comply with the provisions of § 314.60 . [ 57 FR 17983 , Apr. 28 , 1992 , as amended at 58 FR 47352 , Sept. 8 , 1993 ] § 314.97 Supplements and other abbre- changes to an approved viated ...
140. lappuse
... antibiotic application , the agency will determine whether the application or abbreviated antibiotic application may be filed . The filing of an application or abbreviated antibiotic application means that FDA has made a threshold ...
... antibiotic application , the agency will determine whether the application or abbreviated antibiotic application may be filed . The filing of an application or abbreviated antibiotic application means that FDA has made a threshold ...
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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