XTalks

JUNE 21, 2024

The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks. The EFSA concluded that the majority of assessed smoke flavorings posed genotoxicity risks. Other companies, like I.T.S

Genotoxicity 52

Genotoxicity Regulation Production Manufacturing 52

The Pharma Data

MAY 3, 2021

The International Council for Harmonization (ICH) recently announced that its guideline establishing new permitted daily exposures (PDEs) for three residual solvents had reached Step 4, meaning the guideline can now be implemented by regulators. .

Genotoxicity 40

Genotoxicity Regulation Manufacturing Drugs 40

Pharmaceutical Technology

DECEMBER 9, 2022

Our laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and US Food and Drug Administration (FDA) regulations. Quality control release testing.

Development 130

Development Production Manufacturing Vaccine 130

FDA Law Blog

NOVEMBER 20, 2024

For FDA submissions, this strategy can be used to evaluate the biocompatibility endpoints acute, subacute, subchronic, and chronic systemic toxicity, genotoxicity, carcinogenicity, and reproductive/developmental toxicity. By Adrienne R.

Manufacturing 52

Manufacturing Genotoxicity Containment Regulation 52

Pharmaceutical Technology

SEPTEMBER 10, 2008

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

In-Vitro 130

In-Vitro Genotoxicity In-Vivo Development 130

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.

Packaging 89

Packaging Packaging Containment Production 89

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

In-Vivo 44

In-Vivo Manufacturing Engineer Genotoxicity 44