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Dermatologic Corticosteroid BE Guidance

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FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.

FDA Approves New Tibsovo Indication

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FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected ...

UCB Farchim FDA-483 Released

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FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.

FDA Changes Off-Label Approach: Attorney

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Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.

ResMed Recalls Astral 100, 150 Ventilators

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ResMed Ltd. recalls its Astral 100 and Astral 150 ventilators due to what FDA calls a device design issue.

FDA Accepts sBLA for Self-Administered FluMist

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FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMis...

Comments Sought on Export Certificates

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Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated ...

Draft Guide on Unapproved Use Promos

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Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Provide...

Predetermined Change Control Plan Principles

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FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine lear...

Embryll Marketing Unapproved Animal Drug: FDA

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FDA says Embryll Life Sciences is illegally marketing Lanomax, an unapproved animal drug intended to treat cataracts in animals.