Newsletter - June 30, 2022
Breakthrough Therapy Designation is Not Permanent: FDA Guidance Emphasizes
In one of its shortest guidance documents, FDA clarified that the highly coveted and tough to get Breakthrough Therapy Designation (BTD) can be rescinded for multiple reasons. The description of the conditions for rescinding BTDs are not new and have been defined in previous FDA documents, so the purpose...Read More
Scientific Data Versus Anecdotes: What Role Should They Play in FDA Decisions
In an ideal world, regulatory policies and laws are based on unquestionable data from high quality scientific research but should there be other criteria or a standard for weighing unconventional data when the scientific data is not sufficient? There are numerous instances where claims of benefits by patient were...Read More
Breakthrough Therapy Designation is Not Permanent: FDA Guidance Emphasizes
In one of its shortest guidance documents, FDA clarified that the highly coveted and tough to get Breakthrough Therapy Designation (BTD) can be rescinded for multiple reasons. The description of the conditions for rescinding BTDs are not new and have been defined in previous FDA documents, so the purpose...Read More
Scientific Data Versus Anecdotes: What Role Should They Play in FDA Decisions
In an ideal world, regulatory policies and laws are based on unquestionable data from high quality scientific research but should there be other criteria or a standard for weighing unconventional data when the scientific data is not sufficient? There are numerous instances where claims of benefits by patient were...Read More
