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Teva Approval for Zecuity Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of Tevas NDA for Zecuity (sumatriptan iontophoretic transdermal system) after the ...

Clinical Hold on Cellectis CAR T Cell Therapy

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FDA places a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died.

House Appropriators Approve $41 million Boost

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A House appropriations subcommittee approves by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2...

REMS Web Site Updates Listed

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FDA publishes a list of the latest REMS updates for five drugs.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Greiner Bio-One, Luminex Corp. and Vega Life Sciences.

Info Collection on Radioactive Drug Research Committees

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Federal Register notice: FDA sends to OMB an information collection extension for Radioactive Drug Research Committees.

QS, MDR Violations at Luminex Corp.

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FDA warns Luminex Corp. about QS and MDR violations in its production of multiplexing systems.

Zovirax Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Mylans Zovirax (acyclovir) oral capsule, 200 mg, was not withdrawn from sale for reas...

Stakeholder Participation Sought for PDUFA Reauthorization

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FDA says it wants to hear from stakeholders who intend to participate in monthly online consultation meetings during reauthorizati...

FDA Approves Astex Inqovi for MDS, CMML Patients

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FDA approves Astex Inqovi to treat adults with myelodysplastic syndromes.