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FDA Clears Amedica Pedicle Screw System

[ Price : $8.95]

FDA clears an Amedica Corp. 510(k) for the Valeo Pedicle Screw System.

Latest EIRs/483s from FDA Posted

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We post to our Web site the latest FDA-483s and EIRs, etc. we have received from FDA, for Canfield Inc., GRE Fulfillment, Minntech...

Guidance on Impurities in Veterinary Products

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Federal Register Notice: FDA releases a revised ICH guidance on impurities in new veterinary medicinal products, specifically thos...

Guidance on Developing Smallpox Treatments

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on developing drugs for treating or preventing smallpox infection.

FDA OKs Elanco sNADA

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Federal Register Final rule: FDA approves an Elanco Animal Health supplemental NADA for increased monensin in cattle feed containi...

Guidance on Stability Testing Veterinary Drugs

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Federal Register Notice: FDA releases an ICH revised guidance on stability testing of new veterinary drug substances and medicinal...

Guidance on Impurities in Veterinary Substances

[ Price : $8.95]

Federal Register Notice: FDA releases a revised ICH guidance on impurities in new veterinary drug substances.

FDA, Duke Sign MOU

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Federal Register Notice: FDA provides a notice of a memorandum of understanding between FDA and Duke University.

RFID Compliance Guide Extended

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Federal Register Notice: FDA extends the expiration date for the compliance policy guide on radiofrequency identification feasibil...

Eloxatin Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Eloxatin 50 and 100 mg/vial were not withdrawn from sale for reasons of safety or eff...