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17 September 2019
About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biol...

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17 September 2019
The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada.
17 September 2019
The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told...
17 September 2019
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.  
17 September 2019
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday provided an update on its strategy for pharmacopoeial quality standards for biological medicines.
17 September 2019
The US National Academies of Sciences, Engineering and Medicine (NASEM) and the UK's Royal Society issued a call for evidence on human germline genome editing as the two scientific bodies prepare to host an international commission to develop a fr...
16 September 2019
As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern ...