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Will promised Orange Book guidance keep up with technology?

After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies. ....

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Looking Better: Digital therapy reduces liver fat in 90 days

Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available. ....

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TOKYO  Japan's transport ministry is poised to take regulatory action as soon as this month against Toyota Motor affiliate Toyota Industries ov ....

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