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Smiths Medical Class 1 Recall of Syringe Pump

[ Price : $8.95]

Smiths Medical ASD recalls its Medfusion model 4000 syringe pump due to issues associated with earlier software versions.

Guidance on Charging for Investigational Drugs

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FDA posts a final guidance entitled Charging for Investigational Drugs Under an IND Questions and Answers.

Drug Regulatory Site Tours Continue

[ Price : $8.95]

Federal Register notice: FDA announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction...

Panel Backs Abbotts TriClip PMA

[ Price : $8.95]

An FDA advisory committee votes 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs t...

CDER OSI Annual Report

[ Price : $8.95]

The CDER Office of Scientific Investigations (OSI) publishes its FY 2023 annual report with statistics on its consultations in the...

CBER Safety Labeling Changes SOPP

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CBER publishes a standard operating policy and procedure on Section 505 (o)(4) safety labeling changes to drugs approved by NDAs a...

After 12+ Years, FDA Approves Steroid Label Changes

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After 12+ years, FDA accepts a specific labeling change sought for glucocorticosteroids in a Public Citizen 2011 petition, while d...

FDA Clears Masimo OTC Pulse Oximeter

[ Price : $8.95]

FDA clears a Masimo 510(k) for its MightySat Medical, an over-the-counter fingertip pulse oximeter.

Insanitary Conditions at Madhu Instruments

[ Price : $8.95]

FDA warns New Delhi, India-based Madhu Instruments Private Limited that it is producing drugs in insanitary conditions.

CGMP Violations in Ningbo Poplar Records

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FDA warns Chinas Ningbo Poplar Daily-Use about CGMP violations in its manufacturing of over-the-counter drugs.