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The FDA and the Office for Human Research Protections (OHRP) finalized the August 2016 draft guidance for written procedures for institutional review boards (IRBs), and the final guidance includes a clear warning to them. The agencies said in the final that some IRBs have developed written procedures "that simply restate the regulations" in question, but that approach won't work anymore because a working set of procedures will have to provide at a minimum "a comprehensive and critical assessment" of that IRB's responsibilities, functions and organizational structure.

HONG KONG – Chugai Pharmaceutical Co. Ltd., of Tokyo, said its Alecensa (alectinib), an anaplastic lymphoma kinase (ALK) inhibitor, gained expanded approved as a first-line treatment for ALK-positive non-small-cell lung cancer (NSCLC) in Taiwan.

HONG KONG – China's Chia Tai Tianqing Pharmaceutical Holdings Co. Ltd. gained marketing approval for its first innovative treatment for advanced non-small-cell lung cancer (NSCLC), which has the potential of becoming a standard third-line treatment for the disease.

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