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Former FDA Top Lawyer Hails RWE Advances

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Former FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has been the single greatest catalyst for advancing the use ...

Biomarins Short Stature Drug Accelerated Approval

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FDA grants BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric ...

Regulatory Review Period for Sunosi

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Jazz Pharmaceuticals Sunosi...

Info Collection on Generic Drug User Fees

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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Drug User Fee Program.

Heron Submits PONV Drug NDA to FDA

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Heron submits an NDA for its HTX-019 injectable emulsion to prevent postoperative nausea and vomiting in adults.

Lunit AI Breast Cancer Detector Cleared

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FDA clears a Lunit 510(k) for its Insight MMG, an artificial intelligence application for breast cancer detection.

Reminder on Leadless Pacing System Complications

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FDA says it is working with Medtronic to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker ...

FDA Approves New Keytruda Indication

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FDA approves a new renal cell carcinoma indication for Mercks Keytruda.

FDA Says Its Pharmacists Can Help Consumers

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FDA says its Division of Drug Information pharmacists are available to answer consumer questions about taking drugs.

Explore Nitrosamine Impurity Mitigation Strategies: FDA

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FDA updates possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products.