Pharma Industry News

Opinion: STAT+: Five things FDA ad comm members want

As a public health professional, I want people to have access to the health care they need to improve their quality of life. For years I researched available treatments for specific illnesses to determine their safety and efficacy, growing to become an advocate for the development of new treatments for those living with rare diseases.

Yet, for too long, I had no idea the Food and Drug Administration convenes groups of experts, known as advisory committees or ad comms, to review trial data for treatments and make recommendations to inform the FDA’s regulatory decision-making. There are 50 technical and scientific ad comms, made up of more than 200 people, across the FDA. They review the safety and efficacy of medical products.

Even if members of the public don’t know about ad comms, they depend on these expert recommendations, which heavily influence the FDA’s final decision to approve or reject a new treatment.
Continue to STAT+ to read the full story…

As a public health professional, I want people to have access to the health care they need to improve their quality of life. For years I researched available treatments for specific illnesses to determine their safety and efficacy, growing to become an advocate for the development of new treatments for those living with rare diseases.

Yet, for too long, I had no idea the Food and Drug Administration convenes groups of experts, known as advisory committees or ad comms, to review trial data for treatments and make recommendations to inform the FDA’s regulatory decision-making. There are 50 technical and scientific ad comms, made up of more than 200 people, across the FDA. They review the safety and efficacy of medical products.

Even if members of the public don’t know about ad comms, they depend on these expert recommendations, which heavily influence the FDA’s final decision to approve or reject a new treatment.

Continue to STAT+ to read the full story…

About the author

David Miller

a pharmacist, a tech enthusiastic, who explored the Internet to gather all latest information pharma, biotech, healthcare and other related industries.

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