 | 1999 - 372 lapas
...reference as permitted in §314.200(c)(2)) all studies and information specified in §314.200(d). (WARNING: A willfully false statement is a criminal offense,...investigations meeting each of the precise elements of §314.126 and, for a combination drug product, §300.50, showing effectiveness have been identified.... | |
 | 1990 - 1086 lapas
...reference as permitted in $314.200(0(2)) all studies and information specified in $ 314.200(d). (WARNING: A willfully false statement is a criminal offense,...investigations meeting each of the precise elements of § 314.126 and, for a combination drug product, § 300.50, showing effectiveness have been identified.... | |
 | 1996 - 1130 lapas
...information specified in $314.200(d). (WARNING: A willfully false statement Is a criminal offense, 18 U.8.C. 1001.) (7) Separation of functions. Separation of...investigations meeting each of the precise elements of §314.126 and, for a combination drug product, §300.50, showing effectiveness have been identified.... | |
 | 1998 - 1162 lapas
...hearing, and any proposed order denying a hearing and response under paragraph (b)(8) (ii) or (ill) of this section will be submitted to the Office of...investigations meeting each of the precise elements of §314.126 and, for a combination drug product, §300.50, showing effectiveness have been Identified.... | |
 | 1995 - 1186 lapas
...issue. Separation of .m.-tlons on all issues resumes upon isuance of a notice of hearing. The Ofice of the General Counsel, Department of Health and Human...investigations meeting each of the precise elements of §314.126 and, for a combination drug product, ! 300.50. showing effectiveness have been identified.... | |
 | 1991 - 1218 lapas
...for hearing. (1) Where a specific notice of opportunity for hearing (as defined in paragraph (a)(l) of this section) is used, the Commissioner will enter...investigations meeting each of the precise elements of § 314.126 and, for a combination drug product, § 300.50, showing effectiveness have been identified.... | |
 | 1998 - 1120 lapas
...for hearing. (1) Where a specific notice of opportunity for hearing (as defined in paragraph (aid> of this section) is used, the Commissioner will enter...precludes the refusal to approve the application or abbreviated application or the with-drawal of approval of the application or abbreviated application;... | |
 | 2001 - 398 lapas
...for hearing. (1) Where a specific notice of opportunity for hearing (as defined in paragraph (a)(1) of this section) is used, the Commissioner will enter...precludes the refusal to approve the application or abbreviated application or the withdrawal of approval of the application or abbreviated application;... | |
 | 1993 - 1052 lapas
...for hearing. (1) Where a specific notice of opportunity for hearing (as defined in paragraph (a)(l) of this section) is used, the Commissioner will enter...precludes the refusal to approve the application or abbreviated application or the withdrawal of approval of the application or abbreviated application;... | |
 | 1981 - 1252 lapas
...opportunity for hearing (as defined in paragraph (a XI) of this section) is used, it shall state that, if it conclusively appears from the face of the data,...or the withdrawal of approval of the application, eg, no adequate and well-controlled clinical investigations meeting each of the precise elements of... | |
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A person who requests a hearing may not rely upon allegations or denials but is required to set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing with respect to a particular drug product specified... 
