Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Agency IQ

JULY 13, 2023

Consequently, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and flooring felt, rollboard, and corrugated, commercial, or specialty paper. However, the majority of this ban was overturned by Corrosion Proof Fittings v. EPA, 947 F.2d 2d 1201 (5th Cir.

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The Pharma Data

JUNE 18, 2021

SYRIZI (risankizumab) [Package Insert]. Presented at Digestive Disease Week ® (DDW) Virtual Conference 2021, May 21–23. The Facts about Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation of America. Available at: [link]. Accessed on April 9, 2021. Crohn’s disease. Symptoms and Causes. Mayo Clinic. Available at: [link].

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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

JUNE 18, 2021

Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 7 VENCLEXTA (venetoclax) [Package Insert].

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The Pharma Data

FEBRUARY 22, 2021

RINVOQ (upadacitinib) [Package Insert]. Access Economics Pty Limited. Available at: [link]. Accessed on February 12, 2021. The Facts about Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation of America. Available at: [link]. Accessed on February 12, 2021. Ulcerative colitis. Symptoms and Causes. Mayo Clinic. AbbVie Inc.

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Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JUNE 18, 2021

SKYRIZI (risankizumab) [Package Insert]. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. The Facts about Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation of America. Available at: [link]. Accessed on May 21, 2021. Crohn’s disease. Symptoms and Causes. Mayo Clinic. Duvallet, E.,

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

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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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FDA FDA Approval Regulations Production 40

Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

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Codon

JULY 27, 2023

These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.”

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Therapies RNA DNA Engineering 52

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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The Pharma Data

JUNE 18, 2021

volume 4, Article number: 4782 (2014) 7 de Rooij MF, Kuil A, Geest CR, et al. 9 VENCLEXTA (venetoclax) [Package Insert].?North Scientific Reports. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. 2012;119(11):2590-2594. April 2020.

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The Pharma Data

JUNE 18, 2021

volume 4, Article number: 4782 (2014). 8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, Scientific Reports. 6 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. 2012;119(11):2590-2594.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. While in a 2014 study published in the journal Biological Trace Elements Research…. Which is a finding that’s backed up by another 2014 human study…. Along with the amount of estrogen-regulating DIM that he added as well. So what’s the fix here?

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Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2014 WL 46696, at *5 (C.D. 3, 2014) (claim dismissed absent any “facts to support that Defendant’s software includes physical items or is a tangible product”); Windsor Auctions, Inc. 2014 WL 1247768, at *3 (E.D.

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Drug & Device Law

FEBRUARY 29, 2024

It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote same) to be a pretty interesting topic. 247d-6d(a)(2)(B).

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Drug & Device Law

FEBRUARY 24, 2022

Because § 343-1(a) applies only to foods, the court’s detailed analysis of the relevant labeling regulations is not directly applicable to drug and device cases. 2014); Caplinger v. One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. Medtronic, Inc. ,

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