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medicines-medical devices-regulatory affairs

  • Clinical trials, TGA (Australia)

TGA (Australia) renames clinical trials CTX scheme to CTA scheme

The TGA has renamed the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme. The change more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA’s…

Read MoreTGA (Australia) renames clinical trials CTX scheme to CTA scheme
  • 6 November 2020
  • Drug regulation, US FDA

Some milestones in the history of US drug regulation

The idea of this post is to provide a snapshot of some milestones in the history of US drug regulation. Medicines regulation is by no means ever perfect but the legislation is constantly evolving. With each evolution, the intent is…

Read MoreSome milestones in the history of US drug regulation
  • 28 September 2020
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