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Takeaways from FDA AI/ML Transparency Workshop

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Two Morrison Foerster attorneys list five takeaways from an FDA virtual public meeting on artificial intelligence/machine learning...

FDA Efforts to Promote Safe Benzodiazepine Use

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CDER associate director for controlled substances Marta Sokolowska shares issues raised at an FDA/Duke-Margolis Center for Health ...

Generally Positive Comments on PDUFA 7 Letter

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Six stakeholders submit their comments on FDAs PDUFA 7 commitment letter.

Cardinal Health Contract on Real World Evidence

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FDA awards Cardinal Health a $750,000 contract to implement an 18-month real world evidence study to help the agency advance RWE i...

Covid Brought FDA Focus on Real-World Data: Report

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A Bloomberg Law report says FDA is likely to place greater emphasis on real-world data in future regulatory decisions.

FDA OKs Labeling Change on Heart Failure Device

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FDA approves a labeling modification on Impulse Dynamics Optimizer Smart medical device, allowing the removal of a normal sinus rh...

Machine Learning Principles for Device Development

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FDA joins with Canadian and UK regulators to promote 10 guiding principles for good machine learning practice for medical devices.

Regulatory Review Period Determined for Xenleta

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Nabriva Therapeutics Xenlet...

Regulatory Review Period Determined for Inrebic

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Impact Biomedicines Inrebic...

ICH Looking to the Future

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The International Council on Harmonizations looks at changes it must make to evolve with the process of drug development in a chan...