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Medexus Pharma Refiles NDA for Treosulfan

[ Price : $8.95]

Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludara...

Philips Discussing Consent Decree Over Respironics Recalls

[ Price : $8.95]

Philips discusses proposed terms of a consent decree with FDA involving the companys troubled Respironics unit and its ventilators...

Biotronik Pays $13 Million Under False Claims Case

[ Price : $8.95]

Medical device maker Biotronik pays $13 million to resolve allegations that it violated the False Claims Act by causing false clai...

Guide on Conducting Remote Regulatory Assessments

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Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Ans...

Zipperer Debarred by FDA for 5 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order debarring Kenneth Zipperer for five years from importing or offering for import any d...

Proposed Rule on New NDC Code Format

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Federal Register proposed rule: FDA proposes to amend its regulations to move to a new format for National Drug Codes.

Unique Device Identification Compliance Date Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Unique Device Identification: Policy Regarding Compliance D...

Baxter Recalls Abacus Label Software App

[ Price : $8.95]

Baxter Healthcare recalls (Class 1) its Abacus software application due to a risk that final printed bag labels for compounded mix...

Sandoz BLA Filed for Tysabri Biosimilar

[ Price : $8.95]

FDA accepts for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogens Tysabri (natalizumab), ...

Draft Guide on Real-time Oncology Reviews

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FDA posts a draft guidance entitled Real-Time Oncology Review (RTOR) that discusses the program and its promotion of earlier submi...