article thumbnail

WuXi STA breaks ground on new Delaware manufacturing facility

European Pharmaceutical Review

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

article thumbnail

Guidance for medicine packaging under Windsor Framework

European Pharmaceutical Review

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. The following new measures are set to be introduced on 1 January 2025. After this date: Under the framework, medicines can have the same packaging and labelling across the UK.

Packaging 100
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The FDA Law Blog

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

FDA 52
article thumbnail

FDA pushes back on approving mirikizumab due to manufacturing issues

Pharmaceutical Technology

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

FDA 52
article thumbnail

Can you get diabetes from eating too much sugar?

The Checkup by Singlecare

The 2020–2025 Dietary Guidelines for Americans recommend that Americans limit the amount of sugar they consume to less than 10% of their daily intake of calories. Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. Added sugar can go by many names.

Labelling 116
article thumbnail

Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

PharmaShots

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).