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FDA-SEC Info Sharing Raises Disclosure, Insider Trading Concerns

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A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden t...

Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition

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A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager...

Priority Review for Roche Enspryng sBLA

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FDA grants a priority review for a Roche sBLA for Espryng to treat myelin oligodendrocyte glycoprotein antibody-associated disease...

BMC Medical Recalls Sleep Apnea Machines

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BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure machine for treating obstructive s...

FDA Partial Clinical Hold on Biohaven Epilepsy Drug

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FDA issues a partial clinical hold on Biohavens opakalim (BHV-7000) due to nonclinical characterization of certain metabolites doc...

3 Observations on XeCare FDA-483

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FDA releases the Form FDA-483 with three observations from an inspection at New Albany, OH-based XeCare.

FDA Open to Alternative Approaches For Psychedelic Drug Trials

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Writing in a in a New England Journal of Medicine article, FDA officials encourage novel approaches for developing psychedelic dru...

Bill to Update FDA Drug Preclusion Rules

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Rep. Diana Harshberger introduces legislation to aid the dietary supplement industry by changing FDAs drug preclusion rules.

Reduced Application Fees Not Sufficient Incentive: Column

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Ovid Therapeutics executive chairman Jeremy Levin says FDA needs to speed its regulatory processes if it wants to persuade compani...

Bayer Gets OK for Lung Cancer Drug

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FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally adv...