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Life Sciences › Marketing › Draft Guidance

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

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Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

MoFo Life Sciences

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

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If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

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Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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