Sponsors responsibility for TGA product recalls

Sponsors responsibility for TGA product recalls

In an era where health and well-being are paramount, the pharmaceutical industry plays a pivotal role in ensuring the safety of consumers. However, the reality is that pharmaceutical TGA recalls can and do occur, posing challenges to sponsors. In this Blog, we shed light on how PharmOut can provide support and expertise preventing these critical…

Cosmetic FDA Regulations (MoCRA)
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Cosmetic FDA Regulations (MoCRA)

New FDA regulations for cosmetic products: Updates to the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 USC 364 (FDA Cosmetic Regulations). MoCRA: FDA cosmetic manufacturing regulations MoCRA: Effective date for FDA Cosmetic Regulations Most of the provisions in MoCRA take effect at the close of 2023. These include mandatory facility…

Digital Health Technologies – Revolutionizing Healthcare
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Digital Health Technologies – Revolutionizing Healthcare

In a world where technology is advancing at an unprecedented pace, the integration of digital health technologies into the healthcare landscape has become increasingly vital. Recognizing the significance of this convergence, the U.S. Food and Drug Administration (FDA) has taken a significant step forward this month (October 2023) by establishing a new Advisory Committee on…

Essential Information for Class IIa & Class IIb Medical Device Listings 
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Essential Information for Class IIa & Class IIb Medical Device Listings 

Navigating the Latest TGA Amendments: Essential Information for Class IIa & Class IIb Medical Device Listings Ever since the shakeup of the European Union (EU) Medical Device Regulations (MDR) in 2017, the Therapeutic Goods Administration (TGA) have adjusted their dependence on utilising the EU as their basis for listing on the Australian Register of Therapeutic…

Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

Recent ISPE Good Practice Guide Changes: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (2021).

What were the changes? In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in…