FDA Round Up

Catch up on the latest FDA updates and regulatory news with Facet Life Sciences’ comprehensive FDA Round-Up reports.

Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations
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Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations

Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations

For life sciences companies navigating the FDA regulatory landscape, Type [...]

Emily Retherford2025-03-07T21:33:20+00:00Blog, Did You Know, Facet By The Numbers, FDA Round Up, PET Radiopharm, Quarterly Update, Regulatory, Spotlight On, trending|

FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance
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FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance

FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance

Effective communication with FDA through various FDA meetings is essential [...]

Emily Retherford2025-03-07T21:34:29+00:00Blog, Did You Know, Facet By The Numbers, FDA Round Up, PET Radiopharm, Quarterly Update, Regulatory, Spotlight On, trending|

Expanded Access & Compassionate Use: FDA Guidelines & Key Facts
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Expanded Access & Compassionate Use: FDA Guidelines & Key Facts

Expanded Access & Compassionate Use: FDA Guidelines & Key Facts

By: Lisa VanLuvanee, Ph.D. Expanded access, also known as compassionate [...]

Emily Retherford2025-03-09T19:28:29+00:00Blog, Did You Know, Facet By The Numbers, FDA Round Up, PET Radiopharm, Quarterly Update, Regulatory, Spotlight On, trending|

What are the Different FDA Meeting Types for Drugs and Biologics?
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What are the Different FDA Meeting Types for Drugs and Biologics?

What are the Different FDA Meeting Types for Drugs and Biologics?

Communication with FDA when developing innovative pharmaceuticals and biologics is [...]

Emily Retherford2025-03-07T21:33:51+00:00Blog, Did You Know, Facet By The Numbers, FDA Round Up, PET Radiopharm, Quarterly Update, Regulatory, Spotlight On, trending|

Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products
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Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products

Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products

By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory Innovator [...]

Emily Retherford2025-03-07T20:25:40+00:00Blog, Did You Know, Facet By The Numbers, FDA Round Up, PET Radiopharm, Quarterly Update, Regulatory, Spotlight On, trending|

New Draft FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices (September 20, 2024)
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New Draft FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices (September 20, 2024)

New Draft FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices (September 20, 2024)

FDA issued a draft guidance for industry and FDA staff [...]

Julie Kirkland2024-10-21T11:38:14+00:00FDA Round Up|

New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)
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New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)

New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)

FDA issued Revision 2 of the guidance for industry Control [...]

Julie Kirkland2024-10-21T11:33:51+00:00FDA Round Up|

Director Jeff Shuren, CDRH Retires
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Director Jeff Shuren, CDRH Retires

Director Jeff Shuren, CDRH Retires

On July 23, 2024, Jeff Shuren, Director of the Center [...]

Julie Kirkland2024-10-21T11:28:27+00:00FDA Round Up|

FDA Round Up – Q1 2024
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FDA Round Up – Q1 2024

FDA Round Up – Q1 2024

FDA ROUNDUP: FDA Urges Sponsors to Conduct Third Party [...]

BarbaraFLS20202024-09-27T19:22:35+00:00FDA Round Up, News Stories|

FDA Round Up – Q4 2023
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FDA Round Up – Q4 2023

FDA Round Up – Q4 2023

FDA ROUNDUP: New FDA guidance: Stimulant Use Disorders: Developing [...]

BarbaraFLS20202024-09-27T19:07:13+00:00FDA Round Up, News Stories|