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Remarks by Acting Commissioner Ned Sharpless at the FDA Public Hearing on The Future of Biosimilar Insulin - 05/13/2019
… icials/remarks-acting-commissioner-ned-sharpless-fda-public-hearing-future-biosimilar-insulin-05132019 … White Oak, MD … thank you for joining us for today’s very important Public Hearing. The world of public health has never been as … treatments and devices. The subject of today’s public hearing -- facilitating the efficient development of …
Remarks by Lauren Silvis, Chief of Staff, to the Consumer Health Products Association Regulatory, Scientific, and Quality Conference - 05/21/2019
… the DFL and labeling are not sufficient. We’re open to hearing from sponsors who want to pursue this approach in the … the regulatory path forward, FDA is holding a public hearing on May 31 to obtain additional scientific data and … related to cannabis and cannabis-derived compounds. This hearing is expected to be an important step in our continued …
Final All Hands Meeting with Dr. Gottlieb - 04/04/2019
… times in the past two years. The only major Congressional hearing where I didn’t testify was the one hearing on OTC drug reform where Janet Woodcock told me I …
Remarks by Commissioner Califf to the 2022 FDLI Annual Conference - 06/14/2022
Remarks by Dr. Woodcock to the Regulatory Education for Industry Conference - 07/19/2021
… time, CBER, are represented at this conference. You’ll be hearing from all three center directors in the plenary …
Remarks by FDA Commissioner Robert M. Califf to the Coalition for Health AI (CHAI) - 03/05/2024
… data as a “one-off” activity. Not surprisingly, I’m hearing that the “effectiveness” metric being used by health …
Remarks by Anna Abram to the Biocom Celebration of Life Dinner - 11/21/2019
… and interchangeable insulin products. We held a public hearing to seek public input on the topic and we have been …