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Human Drugs

USP Launches Nitrosamines Analytical Hub

The United States Pharmacopeia launches its Nitrosamines Analytical Hub to help address the nitrosamine crisis in the U.S.

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FDA General

FDA Bioresearch Inspection Findings Out

FDA annual inspection metrics from its Bioresearch Monitoring program show that the most common clinical investigator inspectional observations involv...

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Medical Devices

First Covid Test Authorized Outside of an EUA

FDA grants Quidel a de novo marketing authorization for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, which is the first tes...

Human Drugs

Determine NMN is a Dietary Supplement: Petition

Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.

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Federal Register

Lithium Citrate Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due to safety or effectiv...

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Human Drugs

FDA Extends Review Date for BioMarins Roctavian

FDA extends to 6/30 the PDUFA action date for BioMarins Roctavian gene therapy for adults with severe hemophilia A.

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Human Drugs

FDA Highlights Proactive and Innovative Opioid Research

An FDA Clinical Pharmacology Corner post highlights four recent agency articles on aspects of its efforts to tackle the opioid epidemic.

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Biologics

Thomas Advanced Medical Illegally Selling HCT/Ps: FDA

FDA warns Thomas Advanced Medical about illegally marketing human cell and tissue products.

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Federal Register

FDA Withdraws Fosun ANDA for Pemoline

Federal Register notice: FDA withdraws approval of a Fosun Pharma ANDA for pemoline tablets after the company requested it be withdrawn.

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Medical Devices

Abbott Alinity I Concussion Blood Test Cleared

FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.