Researchers query FDA about updating requirements for dru...(at maps in 3-D the minute hills and vall...),Health

Scientists suggested the FDA consider other endpoints, like OCT-detected changes in the thickness of the retina or the disappearance of problem blood vessels.

The FDA position is firm yet open. FDA representatives reminded researchers that the FDA sets a high bar for new drug approvals.

The agency might consider a lower bar and different endpoints for clinical trials, provided the degree of risk to the patient is correspondingly smaller and the trial sponsor is able to justify the clinical relevance of the new endpoints.

The FDA representatives also explained several new standards for drugs when two products are used in combination (called combination products or multi-agent products).

The report also reflects discussions about drug safety, post-marketing drug surveillance between eye study designs, mechanisms for obtaining and substantiating data for retinal disease post-marketing, and whether statistically significant differences in visual function outcomes are clinically important.

'/>"/>