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Complete BIO's FDA Communications Survey
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December 31, 2023
BIO is re-launching a streamlined version of our FDA communications survey to gauge the effectiveness of FDA-sponsor interactions during drug development. This brief survey asks about topics such as communications channels, special designations, and clinical holds. The survey is pivotal for BIO’s ongoing efforts to ensure the FDA review process is working as well as it can. In the past, a similar survey has been critical in our continuous efforts to work with FDA on best practices and to reauthorize PDUFA. The results will be incorporated into BIO’s advocacy agenda to ensure a science-driven, innovative, well-resourced FDA. To participate, simply click here to go to the survey, or use the QR code below. After you access the survey, you will receive a personalized link via email. If you don’t see the email, please check your spam folder. Once you receive the link, you can begin the survey, which takes about 5 minutes to complete. Data will be analyzed in aggregate and not on level of an individual company or program to maintain anonymity. You will be asked basic information about your company and programs and provide vital feedback on your experience interacting with FDA. The survey’s clinical program journals are the heart of the survey. Please take a few minutes to answer these questions for each notable interaction with FDA during development. Participating companies will receive exclusive access to survey data during a webinar in 2024. Again, all data and feedback will be anonymized. If you have questions about the survey you may reach out to fdasurveysupport@bio.org. Thank you in advance for your participation in this important effort!
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BIO and ICBA Release Updated Report on Biotechnology’s Role in Meeting UN Sustainable Development Goals
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Agriculture & Environment, Food & Farm Innovation  •  Press Release  •  December 21, 2023
The Biotechnology Innovation Organization (BIO) released an updated report produced in partnership with the International Council of Biotechnology Associations (ICBA) that highlights biotechnology’s role in meeting the United Nations’ 17 Sustainable Development Goals.The report, “Biotechnology: Driving Solutions for Sustainable Development,” underscores the solutions required to confront climate challenges and emphasizes the pivotal role that biotechnology can play in overcoming these challenges.“Societies around the world face a growing number of challenges in terms of enhancing food security, reducing pollution and emissions, and improving health outcomes. Biotechnology can – and often already is – providing tools needed to feed, fuel, and heal communities worldwide. This important research details how best to leverage biotechnology for advancing equity and more sustainable development,” said John Murphy, chief policy officer at BIO.Some key areas outlined in the report where biotechnologies can have an impact include:Contributing to poverty reduction by supporting the resilience of crops and farmers, improving living conditions and health outcomes, and increasing access to affordable medical therapies;Substantially transforming the efficiency of food production with innovations that improve crop yields and the nutritional values of food crops;Enabling the rapid introduction of clinical trials of vaccines, the search for effective therapies, and a deep investigation of both the origins and the ways in which viruses spread;Developing solutions that reduce water usage and waste, and ensure that water is safe from contaminants;Producing fuel alternatives like biofuels and microbial fuel cells, which provide a cleaner and more-sustainable source of energy and can help reduce greenhouse gas emissions; andDeveloping bio-based materials that are biodegradable and reduce waste.Read the full report here.About BIO:BIO is the premier biotechnology advocacy organization…
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BIO Comments to FDA on “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
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BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
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BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)
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A plan for sustainable food security + holiday reading
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Good Day BIO Newsletter  •  December 15, 2023
The U.N. Food and Agriculture Organization (FAO) released a roadmap to reach food security without increasing global temperatures—we have the details and BIO’s response, plus all of your holiday reading. (592 words, 2 minutes, 57 seconds) Good Day BIO will take a holiday break, returning on January 2. We hope you enjoy the season and look forward to seeing you in 2024!
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BIO Applauds U.N. FAO on Food and Climate Roadmap
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Press Release  •  December 14, 2023
The Biotechnology Innovation Organization (BIO) today welcomed the United Nations (U.N.) Food and Agriculture Organization’s announcement of a new roadmap outlining how the world can attain global food security by 2050 without breaching the global warming temperature target of 1.5 degrees Celsius. “BIO applauds the iterative approach outlined by the U.N. Defining specific milestones and setting realistic — yet ambitious — goals to transform agri-food systems will allow us to address climate challenges without endangering food security or agriculture-based livelihoods,” said BIO Chief Policy Officer John Murphy. The U.N. report highlights the pressing need for innovative and sustainable approaches to agriculture, aligning closely with BIO's mission and membership. Biotechnology plays a pivotal role in enhancing agricultural productivity, improving nutritional content, and fostering environmental sustainability — key elements essential to addressing the complexities of global food security, which climate change exacerbates. Specifically, BIO supports these elements of the roadmap: Recognizing the important role that livestock plays in nutrition and employment, while committing to reduce harmful emissions from livestock production through improved genetics, better feed, and other actions; Enhancing the sustainability of aquaculture, a “nutritional powerhouse” according to the FAO that is already low in greenhouse gas emissions; Improving soil health and water quality through regenerative farming practices, reduced chemical usage, better irrigation management and other changes; Reducing deforestation; Decreasing food loss and waste across the value chain from farm to consumer; Lowering emissions from crop production and protecting crops from climate impacts through improved crop breeding and genetics, among other actions; Accelerating bioenergy production, distribution, and adoption; and Protecting an open and rules-based global trading system while…
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Supreme Court to hear case on FDA’s authority
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Good Day BIO Newsletter  •  December 14, 2023
The Supreme Court will hear a case that will determine whether courts can overrule FDA’s authority on drug approvals—here’s what’s happening. Plus, President Biden is expected to tout drug price controls today. (581 words, 2 minutes, 54 seconds)
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