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Momenta Continuing Enoxaparin Sodium Suit

[ Price : $8.95]

Momenta says it will ask the Supreme Court to hear its case against Amphastar for using a Momenta patented method in producing a g...

FDA Approves Cell-cultured Flucelvax for Flu

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FDA approves the first seasonal flu vaccine using cultured animal cells rather than fertilized chicken eggs.

FDA Approves HeartWare Ventricular Assist System

[ Price : $8.95]

FDA approves a HeartWare PMA for its HeartWare Ventricular Assist System, a left ventricular assist device intended for use to sup...

FDA, Dietary Supplement Maker Enter Consent Decree

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A federal judge in Minnesota approves a consent decree between FDA and Pharmacists Ultimate Health for unlawfully distributing una...

FDA Grants Fast Track for Hemophilia A Therapy

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FDA grants Inspiration Biopharmaceuticals fast track status for OBI-1 in acquired hemophilia A.

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Federal Register Notice: FDA releases a draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Ad...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