FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant.

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Agency IQ

FEBRUARY 23, 2024

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. 2030 is a short timeframe for compliance in supply chains.

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Perficient: Drug Development

MARCH 19, 2024

I got an email from Google Cloud Platform today entitled: [Action Required] Upgrade to Artifact Registry before March 18, 2025 This is not the first time Google has discontinued a product I use. The main driver behind the name change it seems is that Artifact Registry can manage more than just containers, such as OS and language packages.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.

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The Pharma Data

SEPTEMBER 6, 2021

The company is piloting this with its Dr.BEST GreenClean toothbrush, which builds new sustainable handle technology onto its previous innovations with sustainable bristles and packaging. The product’s 100% plastic free packaging includes GSKCH’s innovative cellulose window (which is also made with renewable cellulose.

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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. Since that time, the EPA has published additional drafts of the PHGs.

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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

JUNE 7, 2024

The Commission will then republish an updated version of the list by March 19, 2025. Next, companies will have until June 19, 2025, to request that listed substances that they wish to obtain approval for be included in the Commission’s work program for review.

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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

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity.

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Agency IQ

JUNE 21, 2024

At that time, only the Dutch competent authority (one of the five dossier submitters) speculated about the end of the process, stating that the ban was “expected to enter into force in 2025.”

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The Pharma Data

APRIL 7, 2021

Zero plastic packaging for vaccines and ecodesign of products. To reduce its greenhouse gas emissions by 55% by 2030 and contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027.

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Agency IQ

MARCH 15, 2024

At that time, only the Dutch competent authority (one of the five dossier submitters) ventured to speculate about the end of the process, stating that the ban was “expected to enter into force in 2025.” The agency stresses that the individual steps in this process will be announced in parallel with the committee meetings.

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Agency IQ

SEPTEMBER 15, 2023

of the California Safe Drinking Water and Toxic Enforcement Act of 1986, the European Union’s (EU) Regulation on the Registration, Evaluation, Authorization of Chemicals ( REACH, 1907/2006 ), and the EU’s Classification, Labeling, and Packaging Regulation ( CLP 1272/2008 ), among others. The ban will become effective on January 1, 2025.

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Agency IQ

FEBRUARY 12, 2024

In the theme of the planned rule to add additional PFAS to the TRI for 2025 mentioned above, the EPA officially completed the process to add seven PFAS to the TRI on January 9, 2024. 601 , seeks to prohibit PFAS (and other chemicals) for use in materials in packaging and packaging components. Another one of the bills, H.601

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Agency IQ

JULY 26, 2024

Affected stakeholders will then have until January 1, 2025, when the regulation begins to apply, to prepare for compliance with the requirements triggered by the listing of the new substances in annexes I and V of PIC Regulation. Chemical CAS RN (or EC No.)

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Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

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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. Data on these novel approvals is published throughout the year by both CDER and CBER.

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Agency IQ

JUNE 28, 2024

Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025. On June 6, 2023, Maine’s Senate passed a slightly amended version of a new bill to support manufacturers whose products contain PFAS, and sent it to the governor’s desk. The bill also adds new requirements for manufacturers.

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LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Instead, it was based on the large unmet need, the advantages of a unique ADC-based delivery platform, and a strong preclinical data package that supported this strategy. Was that only six months ago?

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Agency IQ

OCTOBER 27, 2023

11/9/2023: Enters into force 11/9/2025: Date of application To contact the authors of this resource, please email Sierra Milam ( smilam@agencyiq.com ). policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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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

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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Agency IQ

JUNE 21, 2024

The delegated regulation will apply beginning January 1, 2025. Industry would benefit from aligned submission packages and less work to create the submissions. The delegated regulation becomes applicable on January 1, 2025. Similarly, if the change has a significant impact, the Type II classification also remains unchanged.

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The Pharma Data

JUNE 18, 2021

The global burden of IBD: from 2015 to 2025. SYRIZI (risankizumab) [Package Insert]. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150. Nov 43(7):503-11.

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Agency IQ

AUGUST 23, 2024

On August 22, FDA finalized guidance that would require all De Novo applications to be provided in eSTAR format as of October 2025. As many commenters noted in the ML-DSF draft guidance docket, CDRH is moving towards requiring submissions in its electronic submissions template and resource (eSTAR).

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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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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 The agency will begin accepting eCTD v4.0 How can you prepare? ICH electronic Common Technical Document – eCTD v4.0

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

NOVEMBER 3, 2023

Shortages Monitoring Platform established by Regulation (EU) 2022/123 Article 13 should be up and running by 2025. Changes that could be implemented rapidly include using different sources of raw materials and/or finished product, packaging, or changes to batch sizes, manufacturing sites, and equipment.

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Agency IQ

DECEMBER 15, 2023

Meanwhile, EPA has extended the release of the final rule for Updates to New Chemicals Regulations under TSCA from April 2024 to February 2025. For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022.

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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

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. Moving forward, confirmatory testing for approved products should be completed by August 1, 2025.

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Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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Agency IQ

MARCH 29, 2024

Important comment periods closing in April Title Type Comments Close Proposed Consent Decree, Clean Air Act Citizen Suit Notice 4/4/2024 Listing of Specific PFAS as Hazardous Constituents Proposed Rule 4/8/2024 Agency Information Collection Activities; Proposed Information Collection Request; Comment Request; Greenhouse Gas Reduction Fund Accomplishment (..)

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Agency IQ

OCTOBER 27, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C.

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