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BIO Webinar: FDA Answers your Questions about the STAR Pilot Program
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February 15, 2024
The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need. In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program. Speakers: Cartier Esham, PhD, Senior Advisor, BIO Lashawn Schnupps, PharmD, Senior Regulatory Project Manager, FDA  Kristy Lupejkis, Deputy Vice President and Chief of Staff, PhRMA
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NM passes clean fuel standard
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Good Day BIO Newsletter  •  February 15, 2024
New Mexico’s legislature passed a clean fuel standard—something BIO’s been working on for a while. Also, reports indicate WTO negotiators could not reach a consensus on expanding the COVID IP waiver ahead of the Ministerial later this month. Here’s what we know. (645 words, 3 minutes, 13 seconds)
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FDA Answers your Questions about the STAR Pilot Program
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Webinars  •  February 15, 2024
The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need. In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.
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Patient with doctor image

Love biotech, love your heart
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Good Day BIO Newsletter  •  February 14, 2024
Happy Valentine’s Day! On the day celebrating love—during American Heart Month—we look at new cardiovascular research and innovations that make us love biotech. Enjoy your chocolate today—because climate change is coming. (522 words, 2 minutes, 36 seconds)
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A cure for the 'pill penalty'
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Good Day BIO Newsletter  •  February 13, 2024
Today, a closer look at why Congress should pass the EPIC Act and end the “pill penalty,” and some ideas on how policy can encourage a more sustainable bioeconomy. (474 words, 2 minutes, 22 seconds)
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AMR researcher brain drain
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Good Day BIO Newsletter  •  February 12, 2024
A new report from the AMR Industry Alliance warns of researchers leaving the field of AMR, and a European Parliament vote cleared the way for potential legislation to ease regulation of some crops altered through “new genomic techniques (NGTs).” (608 words, 3 minutes, 2 seconds)
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Thank You For Confirming
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BIO Business Solutions

CEOs, Senators: Drug revenues drive U.S. innovation
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Good Day BIO Newsletter  •  February 9, 2024
We recap what biopharma CEOs said on Capitol Hill yesterday, and the launch of a new cloud-based platform that would streamline information and data exchange between drug developers and regulators worldwide. (698 words, 3 minutes, 29 seconds)
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