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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Broad Institute

JULY 26, 2022

Learn more COVID-19 portals and datasets Broad data scientists and software engineers have developed several portals and datasets to support COVID-19-related research. Learn more Genotype-Tissue Expression (GTEx) A comprehensive public resource to study tissue-specific gene expression and regulation.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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Agency IQ

JANUARY 19, 2024

The work could represent early steps toward modernizing one part of FDA’s regulation of this complicated product class. Regulatory context: FDA’s work to foster complex generics through the product lifecycle FDA has allocated extensive research funding to support generic drug regulatory science.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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

MARCH 15, 2024

CORE-MD research showcases possibilities of patient-reported outcomes in high-risk device clinical investigations The latest webinar from the CORE-MD consortium presented the group’s research into how patient-reported outcome measures have been used in clinical evaluations of high-risk medical devices. BioMed Alliance, Team-NB).

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment. the PARC partnership with a budget of 400 million euros).

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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 Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML.

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The Pharma Data

NOVEMBER 18, 2020

The consolidated feedback from the physicians who have participated in hands-on workshops, is very positive. The information in this press release is information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation. Breast cancer in UK. Breast cancer is the most common cancer among women in the UK.

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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

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Agency IQ

JUNE 26, 2023

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). regulators.

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Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.

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Agency IQ

OCTOBER 27, 2023

MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans Regulators from the U.S., The regulators suggest that PCCPs need to be transparent, risk-based, bounded and operate throughout the product life cycle. Internationally, regulators are building a framework AI/ML in regulated products.

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Agency IQ

NOVEMBER 20, 2023

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”. If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S. In particular, regulations in both the U.S.

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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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Agency IQ

AUGUST 11, 2023

Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks. Clearly, the scope of the issue has grown substantially compared to what was covered in the initial guidances and AI recommendations provided by regulators in the last several years. To ensure the safety of the U.S.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis. Although the E.U.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 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 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

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

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 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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Regulations Production Clinical Trials Biosimilars 40

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

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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Regulations Production Compliance Pharmaceuticals 40

Agency IQ

AUGUST 4, 2023

Article 13 requires the EU and member states to “pay full regard to the welfare requirements of animals” during policy development addressing areas including research and technological development. Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

To further expand patient input into product development, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products or “OTP” (formerly the Office of Tissues and Advanced Therapies, or “OTAT”) is holding a free public workshop titled, Clinical Trials: The Patient Experience.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Read AgencyIQ’s full analysis of the workshop here. ]

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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

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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