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The results of the 2014 Scope of Practice & Compensation Report for the Regulatory Profession,
consistent with past surveys, show regulatory careers continue to offer
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Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for marketing approval.
The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used these Notified Bodies for certification.
The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research.