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Federal Register

Draft Guide on Medical Countermeasure Voucher Program

Federal Register notice: FDA makes available a draft guidance entitled Material Threat Medical Countermeasure Priority Review Vouchers.

Human Drugs

Draft Guide on Highlights in Prescribing Information

Federal Register notice: FDA announces the availability of a draft guidance entitled Product Title and Initial U.S. Approval in the Highlights of Pres...

Human Drugs

AuroMedics Pharma Recalls 1 Lot of Levofloxacin

AuroMedics Pharma recalls one lot of levofloxacin in 5% dextrose injection 250mg/50mL in a single-use flexible container after it was found to contain...

Medical Devices

Qiagen Gains FDA Approval for Expanded Therascreen Use

FDA approves a Qiagen PMA supplement extending the indications for use of the companys Therascreen EGFR companion diagnostic to guide the use of Boehr...

Human Drugs

Recent PharMedium Inspection Finds Repeat GMP Deviations

A just-concluded FDA inspection cites PharMediums Cleveland, MS manufacturing facility for repeated inspectional observations from earlier agency insp...

Human Drugs

Orphan Drug Status for Enzychem Radiation Syndrome Drug

FDA grants Enzychem Lifesciences an orphan drug designation for EC-18 for treating acute radiation syndrome caused by bioterrorism.

FDA General

Revised Shutdown Plan Sees 58% of FDA Staff Still at Work

A revised HHS contingency staffing plan reveals a higher number of FDA staff would stay on the job than earlier estimated if a government shutdown is ...

Human Drugs

Labeling Highlights Section Draft Guidance

FDA issues a guidance on content and format for two sections in labeling for human prescription drug and biological products.

Federal Register

Debarment Ordered in Unapproved Drugs Case

Federal Register notice: FDA permanently debars William Ralph Kincaid from providing services in any capacity to a person that has an approved or pend...

Medical Devices

Laser Product Conformance Guidance

FDA publishes a draft guidance indicating the agency wont consider whether laser products comply with specific federal regulations if the manufacturer...