Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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The Pharma Data

JUNE 18, 2021

SYRIZI (risankizumab) [Package Insert]. Symptoms and Causes. Mayo Clinic. Available at: [link]. Accessed on April 9, 2021. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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The Pharma Data

FEBRUARY 22, 2021

RINVOQ (upadacitinib) [Package Insert]. ClinicalTrials.gov. Available at: [link]. Accessed on February 12, 2021. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on February 12, 2021. The Facts about Inflammatory Bowel Diseases. Available at: [link].

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The Pharma Data

JUNE 18, 2021

SKYRIZI (risankizumab) [Package Insert]. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on May 21, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. 2011 Nov;43(7):503-11. North Chicago, Ill. AbbVie Inc. .

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

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