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Compliance to convenience: understanding the latest innovations in capsule formulation

Pharmaceutical Technology

Softgel capsules, containing a liquid, paste or emulsion active ingredient, are trusted and favoured by many patients. Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. The best formulation for the job. 200x260/0 (who.int).

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

FDA Law Blog

For protein foods, a 1 oz-eq is: 1 oz game meat or seafood; 1 egg; ¼ cup cooked beans or tofu; 1 tbsp nut or seed butter; ½ oz nuts or seeds. For example, most cheeses will no longer be eligible for the healthy claim because they contain too much sodium. FDA proposes a compliance data of 3 years after the effective date.

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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

Symvivo CEO and founder Alexander Graves told CTV News that the vaccine candidate has a scientific and compliance benefit. Graves explained the gene therapy platform delivers plasmid DNA that enables a patient’s own cells to produce therapeutic proteins that work to clear harmful virus particles from healthy tissues.

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Tara Flour Safety Concerns Prompt FDA Action

XTalks

The FDA’s assessment comes over two years after Daily Harvest’s French Lentil + Leek Crumbles product containing tara flour sickened nearly 400 people. Tara flour is also high in protein — about 43 percent protein by weight — making it an ideal source of plant-based protein.

Protein 52
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BetterLife Engages Eurofins Discovery for its Next Generation Psychedelics 2-bromo-LSD FDA IND-enabling Pharmacology Studies

The Pharma Data

These include in-vitro assays, cell-based phenotypic assays, safety pharmacology and efficacy, ADME toxicology, medicinal chemistry design, synthetic chemistry, and custom proteins and assay development capabilities. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. It is unknown when these changes would go into effect if they are ultimately adopted.

Genome 52