Last week, Teva Pharmaceutical Industries Ltd. and Active Biotech AB announced they were ending the higher-dose portions of two multiple-sclerosis medication studies. The decision came after eight patients suffered nonfatal… Read More
FDA Extends Compliance Date for Menu-Labeling Rule
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Last month, the FDA extended the compliance date for its controversial menu-labeling rule from Dec. 1, 2015 to Dec. 1, 2016. The new requirements apply to restaurants and similar retail… Read More
FDA Approves First 3D Printed Drug
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The U.S. Food and Drug Administration (FDA) approved the first 3D-printed drug this month, Spritam, designed to treat seizures brought on by epilepsy in children and adults. It was developed… Read More
FDA Extends Compliance Date for Menu Labeling
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Last month, the FDA extended the compliance date for its controversial menu-labeling rule from Dec. 1, 2015 to Dec. 1, 2016. The new requirements apply to restaurants and similar retail… Read More
Inquiry Roundup-Drug Formulation
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Regional Drug Delivery Device Require an expert with extensive knowledge of regional drug delivery device markets to help identify suppliers who can manufacture electronic drug delivery devices (smart inhalers, nebulizers,… Read More
Inquiry round up- Medical device
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Medical Device Manufacturing Dear all, We are starting a medical device company related to IVD (its a blood glucose monitoring wearable). We want to make sure to do the right… Read More
APEC Scientists Battle Food Pathogens
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With food and waterborne pathogens one of the leading causes of illness and death in developing countries, food security is an important focus for Asia-Pacific Economic Cooperation (APEC). APEC is… Read More
Groups Petition FDA for Food Packaging Chemical Ban
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Nine consumer and environmental health groups recently petitioned the Food and Drug Administration (FDA) arguing for a ban on some of the chemicals used in food packaging, especially pertchelorate and… Read More
FDA Clarifies Medical Device Update Guidelines
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The FDA recently made an attempt to clarify when a change in a medical device requires a recall or should be considered an “enhancement.” According to a notice published in… Read More
Study Questions FDA Decisions for Medical Devices
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Last month Zintro experts discussed a drive within the medical devices industry to develop consumer-friendly heart devices for the aging population. One example is the Reveal Linq, a $5,000 device… Read More
“Strategy and Preparation of an Investigational Device Exemption (IDE) Application” Presented by Susanne T. Smith
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Medical Device Insights & Innovation Webinar Series – Session 2 Presented by Susanne T. Smith Presenter’s Note: “An investigational device exemption (IDE) approval by the Agency allows an industry Sponsor… Read More
First FDA Approved Competitor in Breast Cancer Testing Market
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NanoString Technologies received FDA approval for its Prosigna Breast Cancer Prognostic Gene Signature Assay last fall. It is the first breast cancer prognostic assay cleared by the FDA for decentralized… Read More
FDA Sets Sights on Laboratory Developed Tests
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According to leading experts, there are over 3,000 Laboratory Developed Tests (LDTs) marketed in the US. LDTs are tests developed by large, medium, small and specialized clinical labs such as… Read More
The Future of Food Additives
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According to a new report from Packages Facts, a Rockville, MD-based market research publisher, consumers are driving a change in the reliance on synthetic and artificial ingredients in food products…. Read More
What To Expect From Gluten-Free Labels
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Last week, the Food and Drug Administration defined 20 parts per million as the gluten limit found in products, which have the gluten-free label. The purpose of the new ruling… Read More
Seeking Experts To Work On FDA Projects
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Institutional Review Board Chairman We require an IRB Chairman expert to provide a written report (and perhaps court testimony) that specifies the obligations of a IRB Chairman when confronted with… Read More
