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QS, MDR Violations at Fresenius Kabi Facility

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FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Iven...

New Dietary Ingredient Notification Guidance

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FDA publishes a guidance on the procedures and timeframes for submitting a required New Dietary Ingredient Notification.

Comments on FDA Guidance Best Practices

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Four stakeholders respond to an FDA request for comment on guidance best practices.

Follow Laws Intent on Drug Innovation: Scott, Carter

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Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match cong...

Genetic Metabolic Diseases Panel Established

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Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic...

Zevra Therapeutics NDA Review Extended

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FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment...

FDA OKs Hugels Frown Lines Neurotoxin

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FDA approves Hugels Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.

Panel to Meet on Next Covid Vaccine Makeup

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Federal Register notice: FDA announces a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss the s...

Hold Lifted on Iovance Lung Cancer Trial

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FDA removes a partial clinical hold on Iovance Biotherapeutics IOV-LUN-202 trial investigating the companys LN-145 TIL cell therap...

SpringWorks Rolling NDA for Mirdametinib

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SpringWorks Therapeutics commences a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adu...