Drugs, generic Enforcement Act

Generic Drug Enforcement Act, 13 686 Generic drugs, 21 575-576 Generic exposure assessment, in industrial hygiene, 14 220 Genes... 

GDEA Generic Drug Enforcement Act (Elnited States)... 

Generic Drug Enforcement Act of 1992. The following sections summarise some of the more important enforcement provisions used by FDA to regulate all pharmaceutical products. 

Generic Drug Enforcement Act (1992). This law imposes debarment and other remedies for criminal convictions based on activities relating to the approval of ANDAs. 

Certification that the applicant did not and will not use services of any person or firm debarred under the 1992 Generic Drug Enforcement Act. In order to prepare this certification, appropriate certifications should be obtained from all contractors used... 

Generic Drug Enforcement Act. Precipitated by illegal acts involving abbreviated NDAs. Result Created debarment penalty and initiated PAIs for all drug applications. 

FDA has available to it a wide variety of formal and informal enforcement authorities under the FD C Act. They apply equally to all products regulated by FDA. For generic drugs, FDA also can rely upon the provisions of the Generic Drug Enforcement Act of 1992. The following sections summarise some of the more important enforcement provisions used by FDA to regulate all pharmaceutical products. 

Generic Drug Enforcement Act imposes debarment and other penalties for illegal acts involving abbreviated drug applications. 

---