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 100.
108. lappuse
... certification— ( 1 ) Contents . A 505 ( b ) ( 2 ) application is required to con- tain the following : ( i ) Patents claiming drug , drug product , or method of use . ( A ) Except as provided in paragraph ( 1 ) ( 2 ) of this section , a ...
... certification— ( 1 ) Contents . A 505 ( b ) ( 2 ) application is required to con- tain the following : ( i ) Patents claiming drug , drug product , or method of use . ( A ) Except as provided in paragraph ( 1 ) ( 2 ) of this section , a ...
109. lappuse
... certification " Paragraph IV Certification " . This certification shall be submitted in the following form : I , ( name of applicant ) , certify that Patent No. ( is invalid , unenforceable , or will not be infringed by the manufacture ...
... certification " Paragraph IV Certification " . This certification shall be submitted in the following form : I , ( name of applicant ) , certify that Patent No. ( is invalid , unenforceable , or will not be infringed by the manufacture ...
110. lappuse
... certification for each rel- evant patent . ( 6 ) Amended certifications . A certifi- cation submitted under paragraphs ( i ) ( 1 ) ( i ) through ( i ) ( 1 ) ( iii ) of this section may be amended at any time before the effective date of ...
... certification for each rel- evant patent . ( 6 ) Amended certifications . A certifi- cation submitted under paragraphs ( i ) ( 1 ) ( i ) through ( i ) ( 1 ) ( iii ) of this section may be amended at any time before the effective date of ...
111. lappuse
... certification that the applicant or its predecessor in interest provided substantial support for the clinical investigation ( s ) that is essential to the approval of its applica- tion , and information supporting the certification . To ...
... certification that the applicant or its predecessor in interest provided substantial support for the clinical investigation ( s ) that is essential to the approval of its applica- tion , and information supporting the certification . To ...
112. lappuse
... certification of inva- lidity or noninfringement of a pat- ent . or ( a ) Notice of certification . For each patent which claims the drug or drugs on which investigations that are relied upon by the applicant for approval of its ...
... certification of inva- lidity or noninfringement of a pat- ent . or ( a ) Notice of certification . For each patent which claims the drug or drugs on which investigations that are relied upon by the applicant for approval of its ...
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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