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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites A & D Electronics (Shenzhen), Ansar Group, Atrium, CocoKefir, Yelena Dzebovskaya...

Comments Sought on NADA Paperwork

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Federal Register Notice: FDA seeks comments on paperwork associated with applications for new animal drugs.

Guidance on IRB Responsibilities

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Federal Register Notice: FDA releases a draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Ad...

Guidance on Anticoccidial Drugs In Food-Producing Animals

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Federal Register Notice: FDA releases a guidance, Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.

ICH Guidance on Q11 Development/Manufacture of Drug Substances

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Federal Register Notice: FDA releases an ICH guidance, Q11 Development and Manufacture of Drug Substances.

FDA Posts Therapeutic Data Standards

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Federal Register Notice: FDA posts on its Web site a roadmap of its current thinking on therapeutic priority area data standards f...

House Committee Seeks FDA Timelines on NECC Actions

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House Energy and Commerce Republican leaders ask FDA commissioner Margaret Hamburg for timelines and internal communications relat...

FDA Clears TomTec Imaging Software

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FDA clears a TomTec Imaging Systems 510(k) for its new Image-Com 5 software solution.

Public Citizen Calls for Probe on CMS Role in Compounding

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Public Citizens Health Research Group has called for an HHS Inspector General investigation into whether financial incentives crea...

HeartSine Class 1 Recall on Samaritan Defibrillators

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HeartSine begins a Class 1 recall involving certain Samaritan 300/300P Public Access Defibrillators after determining they may i...