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

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Drug Discovery World

AUGUST 16, 2022

These observations may come to light in the clinic, but these disparities can be attributed to every phase of the drug development pipeline – clinical trials, translational research and, ultimately, drug discovery. . Additionally, the lack of diversity in patients participating in clinical trials can also contribute to cancer disparities.

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Research Clinical Trials Trials Drug Development 130

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

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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FDA Science Regulations Production 40

Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. Throughout the 1940s, several U.S. coli in mice.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. Throughout the 1940s, several U.S. coli in mice.

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