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Repeat Observations in Integra FDA-483

[ Price : $8.95]

FDAs New Jersey District Office releases an FDA-483 detailing eight violations found at Integra LifeSciences.

FDA Will Review Onyx Myeloma Drug NDA

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FDA says it will review an Onyx NDA for carfilzomib to treat some patients with multiple myeloma.

10 Objectionable Conditions Found at Zimmer Facility.

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FDA releases an FDA-483 detailing 10 inspectional observations made at Zimmer, Inc.

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Federal Register Notice: FDA releases a draft guidance on use of nucleic acid tests on pooled and individual samples from blood do...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

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

Takeda NDA for Combo Diabetes Therapy

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Takeda files an NDA for alogliptin/metformin, a fixed-dose combination therapy for treating patients with Type 2 diabetes.

WLF Sides with Par on First Amendment Scuffle with FDA

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The Washington Legal Foundation says Par Pharmaceuticals has a good chance of prevailing in its recent First Amendment suit agains...

Comments Sought on Tobacco Retailer Training

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Federal Register Notice: FDA seeks comments on information collection provisions of a draft guidance on tobacco retailer training ...

Guidance on Radiopharmaceutical Late Radiation Tox Studies

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A new FDA guidance provides recommendations for designing nonclinical late radiation toxicity studies to determine potential late ...