Agency IQ

JUNE 7, 2024

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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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

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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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

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

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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. Upon approval, the sponsor was tasked with a dozen Post-Marketing Requirements (PMRs) and Commitments (PMCs), notably including a confirmatory study for accelerated approval.

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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 ). Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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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

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 anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ] the drug and device) of the combination product.

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Agency IQ

JULY 8, 2024

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

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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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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. This trio of documents are known collectively as the Modifications Guidance documents.

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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

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. the drug and device) of the combination product.

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Agency IQ

NOVEMBER 3, 2023

Several pandemic-era mechanisms to monitor medicine supply and prevent shortages are still in effect Article 81(2) of Directive 2001/83/EC obligates marketing authorization holders to “ensure appropriate and continued supplies” of an authorized medicine. The provision aims to ensure patient access to medicines where they have been marketed.

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Agency IQ

AUGUST 11, 2023

The FDA estimated that the products containing the affected API had likely been on the market for about four years before this discovery. The 2014 guideline established a baseline for measuring and reporting genotoxic impurities during development and following market authorization. To ensure the safety of the U.S.

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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

MARCH 29, 2024

April 2024 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) 2040-AG02 EPA supports market-based mechanisms, including water quality trading under the Clean Water Act (CWA). EPA plans to continue its outreach efforts with affected parties.

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Agency IQ

OCTOBER 27, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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Agency IQ

JUNE 16, 2023

This action proposed the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. For increased flexibility in bringing PIPs to market, a developer can also submit both. Proposed Rule Stage San Joaquin Valley PM2.5

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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. and the E.C.

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