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FDA Contest for Developing Naloxone Mobile App

[ Price : $8.95]

FDA announces a Naloxone App Competition, a public contest focused on developing a mobile phone application that can connect opioi...

Comments Sought on Scheduling Changes for 12 Controlled Drugs

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Federal Register Notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of contr...

Docket Created for Biomarkers Used in Novel Drug/Biologic Approvals

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Federal Register Notice: FDA creates a docket to receive suggestions, recommendations, and comments on a list of biomarkers that w...

Notice on Biosimilar Patent Dispute in Amgen v. Sandoz

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Federal Register Notice: FDA publishes a notice that an applicant for a proposed biosimilar product notified the agency that a pat...

FDA Seeks Comments on Social/Behavioral Research Efforts

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Federal Register Notice: FDA seeks public comments on a proposed collection of certain information to support social and behaviora...

Draft Guide on Nonclinical Evaluation for Anticancer Drugs

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Federal Register notice: FDA posts a draft guidance entitled S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and...

FDA/Health Canada Public Meeting on ICH Efforts

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Federal Register Notice: FDA announces a public meeting entitled Health Canada and FDA Joint Public Consultation on International ...

FDA Approves Bayers Kyleena Intrauterine Device

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FDA approves Bayers Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system for...

Public Meeting on Biosimilar User Fee Reauthorization

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Federal Register Notice. FDA announces a public meeting to discuss proposed recommendations for reauthorizing the Biosimilar User ...

Public Meeting on Drug Supplier Product ID Requirements

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Federal Register Notice: FDA annouces a public meeting entitled Progress Toward Implementing the Product Identification Requiremen...