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Federal Register notice: FDA posts a draft guidance entitled S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and...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

Woodcock Upheld by Califf in Duchenne Drug Appeal

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In an unprecedented move, FDA commissioner Robert Califf upholds CDER director Janet Woodocks unusual role in reviewing and approv...

FDA, University of MD Host Clinical Investigator Training

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Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation plans a thre...

ICH Guidance on Nonclinical Studies for Anticancer Agents

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FDA posts an International Conference on Harmonization draft guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals...