The Food and Drug Administration approval process can be like navigating a landmine for health startups hoping to get through regulations and begin selling to the American public. YC company Enzym.io hopes to help these small businesses out by automating the process for them. Biomedical engineer Jared Seehafer came up with the idea through his own experience consulting with health companies… Read More

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Topics:  the food   drug administration   american   enzym   seehafer   read more   startups   health   process   
BING NEWS:
  • Eli Lilly seeks FDA’s OK to expand Zepbound’s uses to include sleep apnea
    Eli Lilly & Co. said Friday that it has applied for U.S. regulatory approval to expand the use of its weight-loss drug Zepbound to include treatment of sleep apnea, as new data show the drug may help ...
    06/21/2024 - 9:48 am | View Link
  • FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability
    The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish ...
    06/20/2024 - 1:21 pm | View Link
  • FDA Rule on Laboratory-Developed Tests Could Shake up Clinical Mass Spectrometry Space
    The rule could boost Roche's planned launch of an FDA-cleared mass spec system while requiring other vendors to rethink their clinical strategies.
    06/19/2024 - 7:39 am | View Link
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