FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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Agency IQ

MARCH 15, 2024

BY WALKER LIVINGSTON, ESQ | MAR 13, 2024 2:33 PM CDT Background: CalRecycle and plastic waste regulations in California The California Department of Resources Recycling and Recovery (CalRecycle) oversees the state’s initiatives towards reducing waste and reusing materials. That amount will increase to 40% in 2030 and 65% in 2032.

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Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids. 2024 [cited 2024 Oct 28]. Labcompare.

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Agency IQ

MAY 10, 2024

BY WALKER LIVINGSTON, ESQ | MAY 7, 2024 10:50 PM CDT Background: PFAS Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

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Agency IQ

AUGUST 4, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging.

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Agency IQ

AUGUST 30, 2024

The good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

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Agency IQ

AUGUST 23, 2024

BY Scott Stephens, MPA | Aug 19, 2024 9:33 PM CDT Background: classifying chemicals in the EU The EU uses the United Nations (UN) Globally Harmonized System (GHS) as the basis for classifying, labeling and packaging hazardous substances and mixtures. Currently, the CLP is aligned with the seventh revised edition of the GHS.

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Agency IQ

FEBRUARY 23, 2024

NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. BY WALKER LIVINGSTON, ESQ | FEB 22, 2024 2:52 PM CST Background: PFAS Per- and polyfluoroalkyl substances (PFAS) are a wide range of synthetic organic chemicals that have been produced since the 1940s.

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Agency IQ

SEPTEMBER 15, 2023

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. On July 1, 2021, DTSC designated carpets that contain PFAS as a Priority Product under agency regulations.

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Agency IQ

JUNE 7, 2024

Figure 1 shows the designations by year since 2017 and through June 4, 2024. There are two codes that all 49 Notified Bodies received designation to – devices with a measuring function (MDS 1010) and devices that require packaging/labeling (MDT 2011). DEKRA received the first IVDR designation in October 2019. There are a handful.

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Agency IQ

JUNE 17, 2024

BY SCOTT STEPHENS, MPA | JUN 10, 2024 10:26 PM CDT Switzerland and the EU’s impact on Swiss chemical regulations Though located in the heart of Europe, Switzerland is not a member of the European Union , nor of the European Economic Area (EEA). While all these changes will impact compliance with Swiss chemical and biocides laws (i.e.,

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Agency IQ

JULY 26, 2024

BY SCOTT STEPHENS, MPA | JUL 23, 2024 10:04 PM CDT Regulatory background 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. Chemical CAS RN (or EC No.) To contact the editor of this piece, email Kari Oakes ( koakes@agencyiq.com ).

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. This marks the first update to the list, which first debuted in July 2023.

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Agency IQ

MARCH 7, 2024

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

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Agency IQ

JUNE 17, 2024

BY COREY JASEPH, MS, RAC | JUN 11, 2024 7:07 PM CDT A quick background on harmonized standards What is a standard and how is it used? But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD.

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Agency IQ

JULY 28, 2023

In the Fall 2022 Unified Agenda , the rule was planned for an August 2023 release date, however in the recently released Spring 2023 Unified Agenda, the planned release date has been moved to February 2024. The Maine legislature has pushed back its compliance date for reporting on PFAS-containing consumer products to January 1, 2025.

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JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

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Agency IQ

OCTOBER 27, 2023

aligns the rules with other EU chemicals legislation – notably on biocidal products and classification, labeling and packaging. food packaging, kitchen and tableware and food processing equipment). Following an evaluation, this initiative: · updates the rules on labeling and listing ingredients.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Here, AgencyIQ analyzes the root causes of these delays, and whether a trend could emerge in the coming years.

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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.

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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. and national regulators.

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Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” . | Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits.

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Agency IQ

JUNE 28, 2024

BY WALKER LIVINGSTON, ESQ | JUN 25, 2024 9:26 PM CDT Background: PFAS Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetic organic chemicals that have been used in a wide array of industrial, commercial, and consumer applications since the 1940’s. Case study: California In April 2024, California state Sen.

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Agency IQ

MAY 31, 2024

AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain In May 2024, the FDA’s Molecular and Clinical Genetics Device panel voted 7-2 in favor of the approval of a new blood-based screening test for colorectal cancer, which would be the first blood-based test of this type.

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Agency IQ

DECEMBER 15, 2023

The EPA orders prohibit the nine significant new use notices the company submitted in December 2022 and are effective February 28, 2024. In addition, fluorine gases are used on high density polyethylene (HDPE) plastic packaging to improve container stability. BY PATRICIA ISCARO, ESQ., EPA first discovered this in pesticides.

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Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

JULY 8, 2024

BY RACHEL COE, MSC | JUL 3, 2024 6:11 PM CDT Major milestones in medical gas regulation Medical gases such as oxygen and medical air are widely used in a variety of healthcare and home/community settings. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

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Agency IQ

APRIL 8, 2024

This week, the FDA announced it is finally ready to start accepting adverse event submissions in ICH E2B(R3) format and that the countdown to mandatory compliance with these requirements has begun. Starting just recently in mid-January 2024 , FDA began accepting post-marketing ICSRs in the E2B(R3)-format.

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Agency IQ

JUNE 21, 2024

An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024. BY KIRSTEN MESSMER, PHD, RAC | JUN 20, 2024 11:49 PM CDT Regulatory background: Post-authorization lifecycle management Medicinal products may be authorized nationally in specific E.U.

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Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

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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.

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Agency IQ

DECEMBER 1, 2023

Although the chance of Congress coming together for a budget bill may still appear slim, the government may simply punt the issue until April 2024, when an overall 1% cut to the budget would come into effect. 2018)), the EPA is obligated to complete this final action by May 31, 2024. Federal budget bills. 86 FR 63110). Pruitt, No.

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