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Human Drugs

Bill to Stockpile Pediatric Cancer Drugs

Three Democrat U.S. Reps. introduce the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is an adequate supply o...

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Human Drugs

FDA Needs More Supplement Authority: GAO

The Government Accountability Office says its testing of prenatal dietary supplements found that many had more or less nutrients than listed on the la...

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Human Drugs

Shorla NDA Accepted for Breast/Ovarian Cancer

FDA accepts for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer.

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Human Drugs

Florida Drug Import Plan Non-Starter: Canada

Canadian officials say they will act to prevent Floridas importation of drugs from that country to cause a shortage in Canada.

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Human Drugs

ICH Viral Safety Evaluation Guidance

FDA publishes an ICH guidance on evaluating the viral safety of biotechnology products derived from human or animal cell lines.

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Human Drugs

No Clarity Yet on Ozempic Suicide Risk: FDA

FDA says it has not been able to establish a causal connection between suicidal ideation and drugs like Ozempic and Wegovy and is continuing to review...

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Stakeholders Take Shots at FDA SIUU Communication Guide

Four major stakeholder groups air their disagreement with an FDA revised draft guidance on firms communicating scientific information on unapproved us...

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Medical Devices

Zeta Surgical Cranial Navigation Device Cleared

FDA clears a Zeta Surgical 510(k) for its Zeta Cranial Navigation System.

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Human Drugs

Busse Hospital Recalls Tracheostomy Tray Kits

Busse Hospital Disposables recalls its Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in response to Nurse Assists 11/2023 re...

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Federal Register

Draft Guide on ANDA Reconsideration

Federal Register notice: FDA makes available a draft guidance entitled Requests for Reconsideration at the Division Level Under GDUFA.