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

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

Development 130

Development Production Manufacturing Vaccination 130

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. . RELATED: FDA consults on ICH residual solvent guideline , Regulatory Focus, 26 May 2020.). .

Genotoxicity 40

Genotoxicity Regulation Manufacturing Drugs 40

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. Manufacturers must conduct various tests such as stability and extractables and leachables (E&L) testing for packaging materials and enclosures to meet safety and efficacy guidelines. USP and EP Organizations for Container Regulation. > umbrella).

Packaging 98

Packaging Packaging Containment Production 98

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. This extension does not include potential pediatric exclusivity. About IBRANCE® (palbociclib) 125 mg tablets and capsules.

HR 52

HR Clinical Trials Clinical Trials Containment 52

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. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Manufacturing 59

Manufacturing Genotoxicity Containment Regulation 59