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Federal Register

ANDA Complete Response Letter Guide

Federal Register notice: FDA makes available a final guidance entitled Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Ti...

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Human Drugs

Medexus Pharma Refiles NDA for Treosulfan

Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparativ...

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Medical Devices

Philips Discussing Consent Decree Over Respironics Recalls

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

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Medical Devices

Biotronik Pays $13 Million Under False Claims Case

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

Federal Register

Guide on Conducting Remote Regulatory Assessments

Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Answers.

Federal Register

Zipperer Debarred by FDA for 5 Years

Federal Register notice: FDA issues an order debarring Kenneth Zipperer for five years from importing or offering for import any drug based on his con...

Federal Register

Proposed Rule on New NDC Code Format

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

Federal Register

Unique Device Identification Compliance Date Guide

Federal Register notice: FDA makes available a final guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and...

Medical Devices

Baxter Recalls Abacus Label Software App

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

Biologics

Sandoz BLA Filed for Tysabri Biosimilar

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