FDA Funding

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety: The practice of compounding medicine can provide important public health opportunities. The FDA’s […]

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A Company of One

Can a company of one make a difference in today’s life science industry?  In a recent article by Ron Leuty of BioTechSF apparently so.  Hari Kumar the company’s sole employee recently closed a deal with Roche for 105M upfront payment and 475M based on milestones.  This is based on technology that could lead to new treatments for […]

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CDRH – Recognized Standards

As posted in the Federal Register today (March 14, 2019) closes the comment period on CDRH – Recognized Standards.  Once finalized, this document will list all the CDRH – Recognized Standards as FDA recognized consensus standards and will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Excerpt from List […]

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