FDA Law Blog: Biosimilars

JUNE 25, 2025

The requirement for the single-unit or unit-dose containers is not a substitute for special packaging, i.e., child resistant packaging required for certain products under the Poison Prevention Packaging Act and implementing regulations. See 16 C.F.R.

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Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

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FDA Law Blog: Biosimilars

JULY 15, 2025

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. on June 20, 2023 and will apply starting January 1, 2025. on June 20, 2023 and will apply starting January 1, 2025. The agreement between the European Commission (EC) and the U.K.

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The Premier Consulting Blog

APRIL 27, 2023

Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1

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Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

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Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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FDA Law Blog: Biosimilars

JULY 15, 2025

Kirschenbaum — The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule ( here ), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. The payment limit for most Part B drugs is ASP plus 6 percent. with certain exceptions.

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Broad Institute

MAY 14, 2025

Cas9 ancestor engineered into a compact genome editing tool By Tom Ulrich May 14, 2025 Breadcrumb Home Cas9 ancestor engineered into a compact genome editing tool Researchers adapt a compact RNA-guided enzyme from bacteria for a variety of DNA editing tasks in human cells. Online May 7, 2025. Nature Biotechnology.

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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

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Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.

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Agency IQ

SEPTEMBER 15, 2023

The SCP Regulations define a candidate chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is found on one or more of the authoritative lists specified in section 69502.2(A) The ban will become effective on January 1, 2025. Chapter 54.

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Agency IQ

MARCH 15, 2024

The unprecedented volume of comments received during last year’s public consultation means EU regulators have had to resort to exceptional measures in the REACH restriction procedure as they seek to maintain transparency, objectivity and a high level of quality. See AgencyIQ’s in-depth analysis of this restriction proposal here. ]

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 28, 2023

The agency has kept the expected publication date for the National Primary Drinking Water Regulation (NPDWR) for six PFAS consistent between the Fall 2022 and Spring 2023 Unified Agendas [for an in-depth analysis on the proposed NPDWR, see this AgencyIQ piece ]. To contact the editor of this analysis, please email Patricia Iscaro.

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Agency IQ

JUNE 21, 2024

Five European nations – Denmark, Germany, the Netherlands, Norway, and Sweden –prepared a proposal in early 2023 that would universally restrict PFAS under Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH).

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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

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. In late 2022, the FDA gained new authority related to PCCPs.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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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

NOVEMBER 3, 2023

Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. [See wide level.

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Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025.

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Agency IQ

JULY 22, 2024

AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Data on these novel approvals is published throughout the year by both CDER and CBER.

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

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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

OCTOBER 27, 2023

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

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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

The global burden of IBD: from 2015 to 2025. SKYRIZI (risankizumab) [Package Insert]. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available at: [link].

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