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FDA Outlook for 2022
The US Food and Drug Administration (FDA) continues to juggle enormous Covid-related responsibilities, while simultaneously attempting to make progress on a huge number of important regulatory priorities and programs that are either in need of reform or in the midst of active reform at the agency or at the legislative level. President Biden’s first Senate-confirmed FDA Commissioner is also expected to take the reins in early 2022 and has promised to re-evaluate several challenging areas for the agency, from the labeling for FDA-approved prescription opioids to the proliferation of medical misinformation and false product claims on social media. Among so much other priority work, the Center for Devices and Radiological Health released its first guidance on the process for transitioning emergency-authorized devices and diagnostic tests to “full” clearance or approval at the end of December 2021, finalized De Novo classification process regulations earlier in the year, and has promised to publish a proposed rule to harmonize the Quality System Regulation with ISO 13485:2016 any day now.

Join Joanne Hawana and Benjamin Zegarelli, FDA regulatory attorneys from Mintz, for a fireside chat of policy activities that will likely have the greatest impact on stakeholders in 2022. Their discussion will also consider how the new FDA Commissioner and various proposals working their way through Congress may impact the FDA going forward.

Jan 26, 2022 02:00 PM in Eastern Time (US and Canada)

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