Drug sponsors operating in Australia may in the future have to provide 12 months’ notice to the Therapeutic Goods Administration of a decision to permanently discontinue supplying any reportable medicine in Australia, according to proposals by the regulator.
Australia Seeks To Tighten Drug Shortages/Discontinuations Reporting
The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.
More from Pink Sheet
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
• By
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
More from Distribution/Supply Chain
• By
A declaratory order removing semaglutide from the FDA shortages list duplicates much of the language in a December decision still in litigation that declared Eli Lilly’s tirzepatide products Mounjaro and Zepbound were no longer in shortage.
• By
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.
• By
At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.