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USP Launches Nitrosamines Analytical Hub

[ Price : $8.95]

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

FDA Bioresearch Inspection Findings Out

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

First Covid Test Authorized Outside of an EUA

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FDA grants Quidel a de novo marketing authorization for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, wh...

Determine NMN is a Dietary Supplement: Petition

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

Lithium Citrate Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due t...

FDA Extends Review Date for BioMarins Roctavian

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

FDA Highlights Proactive and Innovative Opioid Research

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

Thomas Advanced Medical Illegally Selling HCT/Ps: FDA

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

FDA Withdraws Fosun ANDA for Pemoline

[ Price : $8.95]

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

Abbott Alinity I Concussion Blood Test Cleared

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