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Newsletter - April 19, 2018
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Lowering Regulatory Standards Encourages Unproven Stem Cell Therapies

There is a general perception that FDA regulations are overly burdensome, FDA takes long time to approve new treatments, and patients can benefit from treatments based on anecdotal data. This led to some laws passed at the state level solely intended to undermine FDA’s oversight...Read More

FDA Reverses Its Decision to Show Anything is Possible with Negotiation 

This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional data requirements listed by FDA at the time of the RTF. The company released a statement claiming that the reversal ...Read More

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