The FDA Commissioner talks to the Director of the Oncology Center of Excellence to discuss several hot topics

[1] The Commissioner of the FDA and the Director of the Oncology Center of Excellence comment on hot regulatory topics

[2] The Center for Drug Evaluation of the State Food and Drug Administration of China issued three draft guidelines for clinical trial guidelines for atopic dermatitis, dry eye syndrome and multiple sclerosis

The FDA Commissioner spoke with the Director of the Oncology Center of Excellence to comment on accelerated approval and single-country clinical trials

Recently, FDA Commissioner Dr.
Robert Califf and FDA Cancer Center of Excellence Director Dr.
Richard Pazdur spoke at the Friends of Cancer Research (Friends of).
Cancer Research) held a dialogue at its annual meeting and shared views
on a number of hot regulatory topics.

In accelerated approval (accelerated On approval, both leaders said reforms are needed to accelerate project approval
.
Dr.
Pazdur reiterated comments previously published in the New England Journal of Medicine, saying that regulators and drug developers need to work together to shorten the time between
accelerated approval and the results of trials that confirm clinical benefit.
Dr.
Pazdur said that when considering accelerated approval of anti-cancer therapies, the Oncology Center of Excellence hopes that drug developers will provide confirmatory clinical trial plans and initiate clinical trials
before accelerated approval.

The study published in the New England Journal of Medicine noted that the median time from accelerated approval to withdrawal of indication due to lack of clinical benefit validation was 3.
8 years if a confirmatory trial was initiated prior to accelerated approval, and extended to 7.
3 years
if a confirmatory clinical trial had not been initiated at the time of accelerated approval.

Dr.
Pazdur speaks to industry media outlet Fierce Biotech also said in the interview that patient registration for full or mostly completed confirmatory clinical trials is not a "one-size-fits-all" criterion for oncology drug developers seeking accelerated approval, and that the FDA will have some flexibility on this requirement for true breakthrough therapies, but may be more stringent
if it is "just another drug.
" FDA Commissioner Robert Dr.
Califf also emphasized the value of the accelerated approval pathway, saying the FDA needs to step up its efforts
to initiate confirmatory clinical trials before accelerated approval is granted.

In the case of single-country clinical trials trials, Dr.
Pazdur said the FDA will place more emphasis on the results of
multi-regional clinical trials.
"We hope that multi-regional clinical trials will represent the world's major International Coordinating Committee (ICH) regions.
.
.
We want patients in North America, Europe, Asia to be well represented.
.
.
This is not to say that all clinical trials need to be conducted in the USA or a specific proportion need to be conducted in the US, but we require that [trials] be representative of all ICH regions
.
”

Dr.
Pazdur also said that the clinical trial ecosystem in the United States also needs to be simplified, and in this regard, the Oncology Center of Excellence will launch a project with the National Cancer Institute (NCI).
The Pragmatica pilot project simplifies the procedures
of certain clinical trials for drugs with known safety profiles.

English link: https://endpts.
com/fda-leaders-califf-and-pazdur-dish-on-accelerated-approval-reforms-single-country-trials-and-an-empty-white-oak/