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Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
Approval Of Ru-486 As A Postcoital Contraceptive, Kari Hanson
Approval Of Ru-486 As A Postcoital Contraceptive, Kari Hanson
Seattle University Law Review
This Comment argues that if RU-486 were approved as a postcoital contraceptive rather than as an abortifacient, the drug would be of greater overall benefit to women seeking to control their fertility. To support the argument that RU-486 should be approved as a postcoital contraceptive, Part II of this Comment examines the background and development of the drug, the controversy it has engendered, and the drug's recently discovered contraceptive potential. Part III provides a short look at the process by which the FDA approves new drugs and discusses how RU-486 would likely progress through this process. Part IV begins by …