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As such, we disagree with the applicant that the devices have no overlap in anatomical indication and that they treat a different patient population

As such, the panel referred to the Centre for Innovation in Regulatory Science (CIRS) data showing the TGAs median approval time of 391 days in 2013fourth out of the six regulators assessed: FDA (USA), Pharmaceuticals and Medical Devices Agency (PMDA, Japan), Health Canada, EMA (EU) and Swissmedic (Switzerland) (median approval time 304, 342, 350, 478 and 511 days, respectively) [12]

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Scientific Identifiers Product Name: L-Glutathione (Reduced Form) 1500 mg Catalogue Number: BWP-GSH-1500 CAS Number: 70-18-8 PubChem CID: 124886 Molecular Formula: CHNOS Molecular Weight: 307.33 g/mol Sequence: -Glu-Cys-Gly Type: Linear Tripeptide (L-isomer, Reduced Form) Form: Lyophilised Solid Purity: 99.1 % (HPLC Verified) Storage: Store at 20 C, protected from light Unit Size: 1500 mg Usage and Reconstitution L-Glutathione is supplied as a lyophilised solid to ensure long-term stability

A comparative study reported that microwave-assisted extraction yielded higher polyphenol content and antioxidant activity than ultrasound-assisted extraction (50)