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CGMP Issues Cited at Hubei Gedian Humanwell

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FDA warns Chinas Hubei Gedian Humanwell Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceu...

FDA Reinspection of Troubled Novo Nordisk Facility

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FDA documents GMP issues at a long-troubled Bloomington, IN, fill-finish facility formerly owned by Catalent and acquired by Novo...

Disc Medicine Says FDA Open to Bitopertin Approval Path

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Disc Medicine says it has reached agreement with FDA on a potential regulatory path forward for its investigational therapy bitope...

Senators Introduce Bill for Homeopathic Product Pathway

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Senators Mike Lee (R-UT) and Tommy Tuberville (R-AL) introduce the Homeopathic Drug Product Safety, Quality, and Transparency Act.

Lilly's Oral GLP-1 Outperforms Oral Semaglutide in Diabetes Trial

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Eli Lilly reports Phase 3 study results showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk'...

AMA Delegates Call for Tighter FDA Oversight of Unapproved Peptides

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Delegates at the American Medical Association's annual meeting vote to support stronger FDA oversight of synthetic peptide product...

Clinical Hold on Quantum IND

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FDA places a clinical hold on Quantum BioPharmas IND for its multiple sclerosis drug candidate Lucid-21-302.

Induced Infringement Decision Analyzed

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Eight Mintz attorneys analyze the recent Supreme Court decision giving generic drug manufacturers a victory in an induced infringe...

FDA AI Inspections Prompts Industry Readiness Strategy Rethink

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Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial int...

Agency Defends Generic Drug Oversight

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FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, i...