News & Analysis as of

Pharmaceutical Industry Final Guidance Premarket Approval Applications

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Hogan Lovells

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

Hogan Lovells on

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

Smart & Biggar

Rx IP Update - March 2019

Smart & Biggar on

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

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