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Home » Topics » Regulatory

Regulatory
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China's state machine is set to drive innovation, but needs more than just drug law reforms

Sep. 25, 2019
By Elise Mak
SUZHOU, China – A recent revision to China's legal infrastructure for the pharma industry represents a concrete step toward bolstering domestic biotech innovation, said stakeholders gathered at last weekend's China Biomed Innovation and Investment Conference.
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More approvals by FDA: Rare disease, oncology and HKEX remain the focus

Sep. 25, 2019
By Elise Mak
SUZHOU, China – The global biotech market continues to look promising and Chinese companies are taking notice as they lay the foundation for new advances.
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Product regulatory actions for Sept. 23, 2019

Sep. 24, 2019

FDA lays framework for engaging patients in device clinical trials

Sep. 24, 2019
By Meg Bryant
BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.
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Is Brazil moving toward a med-tech price cap?

Sep. 24, 2019
By Sergio Held
BOGOTA, Colombia – Last month, Anvisa, Brazil's health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant?
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Regulatory front

Sep. 24, 2019

Crysvita approved in Japan for FGF-23-related hypophosphatemic rickets and osteomalacia

Sep. 23, 2019

Regulatory front

Sep. 23, 2019

Product regulatory actions for Sept. 20, 2019

Sep. 23, 2019

Biotech companies lead big pharma in new medicine approvals

Sep. 23, 2019
By Peter Winter
The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually. 
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