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. and the E.C.

FDA 40

FDA Science Regulations Production 40

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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

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. ].

FDA 40

FDA Disease Regulations Production 40

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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Production Regulations 40

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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FDA Science Regulations Production 40

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.

Research 130

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.

Regulations 40

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.

DNA 52

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.

FDA 40

FDA Science Biosimilars Regulations 40