Tag Archives: FDA

How Industry Rates Interactions with the FDA

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Kicking off day one of the BIO CEO & Investor Conference in New York City, panelists in the ‘How Industry Rates Interactions with the FDA’ session brought attendees good news – communication with the FDA has improved overall. “The improvements we have seen in increased communications between FDA and sponsors is based on a continuous dialogue that has been established over the past several years in which BIO has been at the forefront,” said Jonathan Read More >

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Survey Shows Americans Support Labeling Foods Containing DNA

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A recent survey by the Oklahoma State University Department of Agricultural Economics finds that over 80 percent of Americans support “mandatory labels on foods containing DNA,” about the same number as support mandatory labeling of GMO foods “produced with genetic engineering.” Washington Post reported on the survey:   If the government does impose mandatory labeling on foods containing DNA, perhaps the label might look something like this: WARNING: This product contains deoxyribonucleic acid (DNA). The Surgeon General has Read More >

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Updated Legal and Regulatory Frameworks Needed for Biosimilars

Jim Greenwood

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. We call on the FDA to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological. There has been positive momentum recently, however, we believe the appropriate way to develop policy on such Read More >

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Cervical Health Awareness Month: 5 Things You Need to Know about HPV

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Approximately 79 million Americans have HPV (human papillomavirus), which is a major cause of cervical cancer. HPVs are a group of more than 150 related viruses. More than 40 of these viruses can be easily spread through direct skin-to-skin contact. Most infections with high-risk HPVs do not cause cancer. Many HPV infections disappear within two years, but infections lasting several years may increase the risk of developing cancer. High-risk HPV infection accounts for approximately five Read More >

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Exclusive FDA Survey Webinar

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BIO is conducting an exciting new survey designed to measure FDA/Sponsor Interactions During Drug Development.  We are excited to announce an exclusive webinar for survey participants only to reveal the preliminary results of the study.  Participants are invited to attend this webinar to gain exclusive access to survey insights and hear analysis of the survey data from regulatory experts, including FDA staff. This exciting webinar opportunity is scheduled for Wednesday, January 28 at 1:00 pm Read More >

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