The report included three recommendations that it believed FDA should immediately implement, including:
Keeping proper documentation of the agency’s interactions with drug companies
Creating clear protocols for when the agency can create joint presentations with companies
Updating its guidance for the development of new Alzheimer’s drugs
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.
There was a congressional inquiry that then tasked the FDA to:
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.