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
... 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 noninfringement of a ...
... 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 noninfringement of a ...
100. lappuse
... Subpart D - FDA Action on Applications and Abbreviated Applications 314.100 Timeframes for reviewing applica- tions ... Subpart E - Hearing Procedures for New Drugs 314.200 Notice of opportunity for hearing ; notice of participation and ...
... Subpart D - FDA Action on Applications and Abbreviated Applications 314.100 Timeframes for reviewing applica- tions ... Subpart E - Hearing Procedures for New Drugs 314.200 Notice of opportunity for hearing ; notice of participation and ...
173. lappuse
... Subpart G - Miscellaneous Provisions SOURCE : 50 FR 7493 , Feb. 22 , 1985 , unless otherwise noted . Redesignated at 57 FR 17983 , Apr. 28 , 1992 . §314.410 Imports and exports of new drugs and antibiotics . ( a ) Imports . ( 1 ) A new ...
... Subpart G - Miscellaneous Provisions SOURCE : 50 FR 7493 , Feb. 22 , 1985 , unless otherwise noted . Redesignated at 57 FR 17983 , Apr. 28 , 1992 . §314.410 Imports and exports of new drugs and antibiotics . ( a ) Imports . ( 1 ) A new ...
177. lappuse
... Subpart H - Accelerated Approval of New Drugs for Serious or Life - Threatening Illnesses SOURCE : 57 FR 58958 , Dec. 11 , 1992 , unless otherwise noted . § 314.500 Scope . This subpart applies to certain new drug and antibiotic ...
... Subpart H - Accelerated Approval of New Drugs for Serious or Life - Threatening Illnesses SOURCE : 57 FR 58958 , Dec. 11 , 1992 , unless otherwise noted . § 314.500 Scope . This subpart applies to certain new drug and antibiotic ...
179. lappuse
... Subpart A - General Provisions Sec . 316.1 Scope of this part . 316.2 Purpose . 316.3 Definitions . 316.4 Address for submissions . Subpart B - Written Recommendations for Investigations of Orphan Drugs 316.10 Content and format of a ...
... Subpart A - General Provisions Sec . 316.1 Scope of this part . 316.2 Purpose . 316.3 Definitions . 316.4 Address for submissions . Subpart B - Written Recommendations for Investigations of Orphan Drugs 316.10 Content and format of a ...
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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