Newsletter - April 19, 2018
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This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional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
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This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional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
