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BIO Comments to FDA (Docket No. FDA-2023-N-0398) on Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
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Letters, Testimony & Comments  •  May 26, 2023
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
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EPA's 'inexplicable' rule on PIPs
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Good Day BIO Newsletter  •  May 26, 2023
Before you head out for the holiday weekend, we have news on the EPA’s final rule on Plant Incorporated Protectants—plus, weekend reading. We’ll be back on Tuesday, May 30. Enjoy the weekend! (542 words, 2 minutes, 42 seconds)
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BIO Comments to the FDA on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (Docket No. FDA–2023-D-0110)
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Letters, Testimony & Comments  •  May 25, 2023
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.
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BIO Statement on PIPs Rule: EPA Misses Opportunity to Advance Food, Ag Innovation
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Press Release  •  May 25, 2023
The following statement concerning the Environmental Protection Agency’s final rule on regulation of Plant Incorporated Protectants (PIPs) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) may be attributed to John Murphy, chief policy officer and deputy general counsel for the Biotechnology Innovation Organization (BIO). “EPA’s revisions to the PIPs regulations come at a critical time for technology developers and society as we innovate to meet global challenges including strengthening food security and climate adaptation, mitigation and resilience. EPA had an opportunity to streamline regulations of pesticidal substances in plants and expand exemptions that help bring new, innovative products made with precise gene editing tools to market. The revisions could have helped biotechnology harness the power of science to advance the bioeconomy and feed the world more securely and sustainably, goals that President Biden has declared in his Executive Order on biotechnology and innovation.   “Unfortunately, the agency’s final rule is a hugely missed opportunity. EPA’s rule inexplicably holds PIPs produced via biotechnology to a different standard than the same substances produced via plant breeding. This approach of holding the same or similar products to different standards merely due to their production method is not supported by science. EPA is imposing an extremely narrow exemption and burdensome data requirements that render this an exemption in name only.”
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340B transparency bill advances
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Good Day BIO Newsletter  •  May 25, 2023
A busy pre-holiday Thursday, with activity on 340B in the House yesterday and a look at why Congress must repeal the R&D amortization provision. Plus, BIO just announced a new keynote speaker at the BIO International Convention—we have the details. (665 words, 3 minutes, 19 seconds)
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FDA Commissioner Dr. Robert Califf to Address Medical Misinformation During Keynote Address at BIO International Convention
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Press Release  •  May 25, 2023
BIO CEO Rachel King and Califf will discuss issues impacting FDA and the biotech communityWASHINGTON - (May 25, 2023) – Robert Califf, commissioner of the Food and Drug Administration, will be the keynote speaker on day three of the 2023 BIO International Convention. In a wide-ranging interview on June 7, hosted by Rachel King, CEO of the Biotechnology Innovation Organization (BIO), Califf will discuss the public health consequences of misinformation, threats to FDA’s authority in determining drug safety and efficacy, the pandemic response, the impact of the Inflation Reduction Act, the importance of diversity, equity, and inclusion in biotech, the consequences of health disparities, and more. The BIO International Convention will take place at the Boston Convention and Exhibition Center from June 5 – 8. “Scientific facts and data are at the heart of what we do in the biotech industry,” said King. “We are so pleased that Dr. Califf is joining us, as we Stand Up For Science and fight back against distortions and half-truths that can spread like wildfire in the age of social media. I look forward to discussing this and the myriad of issues facing our industry and the FDA.”  Califf returned to lead the FDA as the 25th commissioner in 2022, having served as the 22nd commissioner in 2016. During his latest tenure as FDA commissioner, he’s weathered a pandemic, attacks on the accelerated approval pathway, and an infant formula shortage. Califf has made fighting misinformation a top priority, citing its spread as a contributing factor to a drop in life expectancy in the U.S. In a recent episode of the I am BIO podcast on misinformation Califf said, “I am deeply concerned and passionate about the issue of misinformation, because it kills people. When we look across the whole spectrum of medicine and how many great technologies we now have that can extend useful life, it's essential that we get truthful, reliable information to people. The purveyors…
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BIO Office Hours: FDA Inspections with PSC Biotech
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May 24, 2023
How do you prepare for an upcoming regulatory inspection? Do fully understand the FDA inspection procedures? What are the steps following inspection close? Ask a PSC Inspection Management Expert during BIO’s Office Hours.   Schedule Office Hour  
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Inquiry Form for Avantor
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BIO Business Solutions
BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry operated by the Biotechnology Innovation Organization (BIO). With more than half a billion in annual sales, BIO Business Solutions® aggregates the purchasing power of over 4,700 life science companies from North America. Companies of all sizes save substantial money each year through this cost-savings program. To request information for the BIO-Avantor Program, please fill the fields below and click the Submit button at the bottom of the form.   MktoForms2.loadForm("//app-ab15.marketo.com", "490-EHZ-999", 3825);
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Are PBMs working in the interest of health care?
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Good Day BIO Newsletter  •  May 24, 2023
Could PBMs provide the bipartisanship we need? Yesterday’s House hearing made us think so. Plus, researchers asked 100 questions facing plant science—and biotech has some answers. (626 words, 3 minutes, 7 seconds)
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How Boston became a 'biotech hub'
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Good Day BIO Newsletter  •  May 23, 2023
A bonus episode of the I am BIO Podcast explores how Boston became a biotech hub—and how you can get in on the action. Plus, climate change is affecting our sleep in more ways than one—here’s what biotech can do about it. (632 words, 3 minutes, 9 seconds)
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