Our modern world needs a modern FDA with the capacity to accelerate access to safe, effective treatments while sustaining U.S. leadership in biotechnology. PDUFA VIII offers a historic opportunity to make the drug review program faster, more consistent, and more transparent by prioritizing core review activities, modernizing processes, strengthening accountability, and embracing patient-centered science.

Over 250,000 Americans, including children, are living with muscular dystrophies, a group of genetic disorders that causes their muscles to grow weaker.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Nearly 60 million Americans, including millions of children, struggle with a mental illness.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Each year, over 80,000 American adults and children are diagnosed with lymphoma, a cancer of the immune system.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Nearly 7 million Americans are living with dementia, a group of progressive brain disorders that affect memory, thinking, and the ability to do everyday things.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

More than 1 million Americans are blind, and more than 12 million Americans are losing their vision.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 6 million Americans are living with Alzheimer's disease, the most common form of dementia.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 65,000 Americans are diagnosed with pancreatic cancer every year.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Nearly 1.5 million older Americans have lost or are losing their vision from wet age-related macular degeneration, also known as wet AMD.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 50,000 Americans, including children, live with some form of myositis.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 60,000 Americans, including many children, are diagnosed each year with leukemia.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 3 million Americans and 50 million people worldwide suffer from epilepsy, a neurological disease that causes recurring seizures.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Over 600,000 Americans suffer from autoimmune nephropathy, which occurs when your immune system attacks your kidneys.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Why do some health plans charge out-of-pocket costs for cancer treatments? Doctor-prescribed treatments authorized by your insurer should have zero copays.

1 in 7 Americans has an autoimmune disease. But some insurance plans charge high out-of-pocket costs for prescribed medicines? Why? We paid our premiums. Don't make patients pay twice.

Why do some health plans charge out-of-pocket costs for cancer treatments? Doctor-prescribed treatments authorized by your insurer should have zero copays.

Why do some health plans charge out-of-pocket costs for chronic conditions like Diabetes? Doctor-prescribed treatments authorized by your insurer should have zero copays.

Why do some health plans charge out-of-pocket costs for chronic conditions like Asthma? Doctor-prescribed treatments authorized by your insurer should have zero copays.

Each year, over 230,000 Americans are diagnosed with lung cancer, the second most common cancer in the United States and the leading cause of cancer-related deaths.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.

Tens of millions of Americans are living with liver disease, which can be caused by heavy alcohol use, a viral infection, a genetic disorder, or problems with a person's metabolism.

Behind every statistic is a person fighting for more time, and behind them is a team of scientists, investors, and patient advocates working toward a cure.