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Human Drugs

Panel Votes Down GSKs Mepolizumab in COPD

FDAs Pulmonary Allergy Drugs Advisory Committee votes 16 to 3 against approving the use of GSKs mepolizumab as an add-on treatment to inhaled corticos...

Federal Register

Info Collection Extension for Product Interruption Notices

Federal Register notice: FDA submits to OMB an information collection extension for Permanent Discontinuation or Interruption in Manufacturing of Cert...

Human Drugs

Probe 2 Unethical Minnesota Tests: Public Citizen

Public Citizen calls on FDA and the HHS Office of Human Research Protections to investigate two clinical trials at a Minnesota hospital involving admi...

Federal Register

Guide on Certain Drug Quality Assessments

Federal Register notice: FDA makes available a draft guidance entitled Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General C...

Human Drugs

SCOTUS Will Hear Preemption Case Appeal

Attorney Joe Hollingsworth says the Supreme Court should reverse a 3rd Circuit ruling that set a high evidentiary burden for drug company preemption c...

Medical Devices

FDA Updates Safety Alert on Zoll LifeVest

FDA updates an earlier safety alert that warned health professionals about Zoll Medicals Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to...

Medical Devices

Updated FDA Mobile Medical App List

FDA releases an updated list of cleared or approved mobile medical applications.

Human Drugs

Establishing Pharmacologic Class MAPP

CDER issues a MAPP on establishing pharmacologic class for use in a drugs labeling Highlights section.

Human Drugs

Agile to Pursue Twirla FDA Appeal

Agile Therapeutics says it will appeal an ODE3 director decision denying its appeal of a complete response letter for its Twirla once-weekly contracep...

Medical Devices

PMA Approved for Magnetic Localization Biopsy Device

FDA approves an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patient...