The latest global regulatory news, changes and updates affecting biopharma, including: SEC: electronic signatures OK; FDA releases more PSGs; HHS sees AI, NLP as regulatory clean-up service providers; MHRA gives ups and downs of reclassifying drugs; TGA: Diabetes risks greater than NDMA risks.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.

PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.

PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.  

Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.

PERTH, Australia – Industry was supportive of most of the changes proposed by Australia’s Therapeutic Goods Administration (TGA) for custom-made and 3D-printed devices. However, the comments also indicated that the current regulatory requirements for custom-made devices are not well understood. The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.