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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
good pay, growth opportunities and challenging and diverse work.
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.
US regulators have finally released the text of a 2009 industry proposal that is set to form the basis of discussion at an upcoming meeting on whether companies should be allowed to "reserve" drug names for late-stage investigational drugs.
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.