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Clarification Sought in Oncology Trial Inclusion Guidance

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Four drug stakeholders ask for changes to an FDA draft guidance on including adolescents in adult oncology trials.

Cianna Medicals SCOUT Reflector Cleared for Broader Use

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FDA clears a Cianna Medical 510(k) to broaden the indication of its SCOUT reflector for use in localization of soft tissue.

Public Hearing on National Drug Code Future Changes

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Federal Register notice: FDA announces an 11/5 public hearing on the future format of the National Drug Code.

Guide on Opioid Use Disorder Trial Endpoints

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FDA posts a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assiste...

Draft Guide on Nicotine-Containing Drug Products

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Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing D...

Alteogen Gains Orphan Status for Cancer Therapy

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FDA grants Alteogen an orphan drug designation for ALT-P7 and its use in treating gastric cancer.

FDA Clears Strata Skin Sciences Laser Dose Tip

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FDA clears a Strata Skin Sciences 510(k) for its Multi-Micro Dose tip accessory for its proprietary Xtrac 308nm excimer laser.

Fast Track for Nohla Therapeutics Dilanubicel

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FDA grants Nohla Therapeutics a fast track designation for dilanubicel (NLA101) for patients with high-risk hematologic malignanci...

FDA Rejects Pain Therapeutics Remoxy NDA

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FDA issues Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone.

FDA Approves Indivior for Monthly Schizophrenia Dosing

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FDA approves an Indivior NDA for Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable for ...