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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

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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

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

Insanitary Conditions at Madhu Instruments

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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.

Information Technology Operating Plan Posted

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The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.

FDA Approves Ipsens Pancreatic Cancer Drug

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FDA approves an Ipsen Biopharmaceuticals NDA for Onivyde (irinotecan liposome) for use in combination with oxaliplatin, fluorourac...

5-Year Debarment for Ross Lucien

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Federal Register notice: FDA issues an order debarring Ross Lucien for five years from importing any drug into the U.S.