Agency IQ

JUNE 26, 2023

While most legislators who voted in favor for this legislation were likely unaware, the European Union is in the process of a dramatic overhaul of its Orphan Drug Regulation by way of a proposed revision of its Pharmaceutical Legislation. Read full AgencyIQ analysis of the workshop here. ].

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. 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.

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Agency IQ

AUGUST 11, 2023

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug.

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Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Drug Discovery World

AUGUST 16, 2022

In recent times, however, governing bodies and pharmaceutical sponsors of clinical studies are starting to identify this as a serious issue and are beginning to enforce representation in trial design.” . It was, therefore, considered cost-prohibitive for pharmaceutical sponsors to set up clinical trials in these locations.

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Research Clinical Trials Trials Drug Development 130

Agency IQ

DECEMBER 15, 2023

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. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration.

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Regulations Compliance Production Government 40

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A writing workshop was followed by pizza and rosé Thanks to everyone who showed up. The results were also published in non-English journals, making them largely inaccessible to Western scientists. Paper by Sha G. in Nature.

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DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A writing workshop was followed by pizza and rosé Thanks to everyone who showed up. The results were also published in non-English journals, making them largely inaccessible to Western scientists. Paper by Sha G. in Nature.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. The workshop will solicit and include industry and public feedback.

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