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FDA Clears Royal Phillips Imaging System

[ Price : $8.95]

FDA clears a Royal Philips 510(k) for the Ingenuity TF PET/MR, a whole body positron emission tomography/magnetic resonance imagin...

FDA Accepts Amarin NDA for High Triglycerides

[ Price : $8.95]

FDA accepts for review an Amarin NDA for AMR101, a prescription-grade omega-3 fatty acid indicated for treating patients with very...

FDA OKs Merial Ltd. sNADA for Veal

[ Price : $8.95]

Federal Register Final rule: FDA approves a Merial Ltd. sNADA to add a warning statement against using eprinomectin topical in pre...

Guidance on Radiopharmaceuticals Toxicity

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Federal Register Notice: FDA releases a guidance, Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceut...

FDA Amends Emergency Authorization for Postal Service

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Federal Register Notice: FDA amends the Emergency Use Authorization for doxycycline hyclate tablet for U.S. postal workers and fam...

Nominations Sought for Science Board

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Federal Register Notice: FDA requests nomination for voting members on the Science Board to the FDA.

Science Board to Meet

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Federal Register Notice: FDAs Science Board will meet 1/6/12 to hear various updates.

FDA, Ranbaxy Nearing Resolution on Data Integrity Issues: Report

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A news report says Ranbaxy Laboratories is close to resolving data integrity and quality control issues involving its generic drug...

Guidance on Blood Donor Testing to Reduce Hepatitis B

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Federal Register Notice: FDA releases a draft guidance on use of nucleic acid tests on pooled and individual samples from blood do...

FDA Approves Mylans Generic Zinecard

[ Price : $8.95]

FDA approves a Mylan ANDA for a generic copy of Pharmacia & Upjohns chemoprotective agent Zinecard.