Sentence examples similar to label claim for a drug from inspiring English sources

They are reliable enough to warrant an approval of a label claim for a new drug.

In addition, there are no currently available instruments for assessing COPD-related dyspnoea that can support a specific label claim for a medicinal product in the USA.

Evidence of content validity is required if a patient-reported outcome (PRO) instrument is used to support a labeling claim for a new product in the United States [ 19].

Two anthelmintic formulations have a label claim for larvicidal therapy of these encysted stages; moxidectin and a five-day regimen of fenbendazole.

The outcome variable was presence or absence of a claim for an antimicrobial drug prescription linked to the index visit.

Labeling claims for OTC orally administered insect repellent drug products are either false, misleading, or unsupported by scientific data.

For 90 years, until 1987, a food product with such a claim on its label was treated as a drug and considered misbranded unless the claim was backed by an approved drug application.

It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling.

Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim.

× 3); or if claims for type 1 diabetes, the patient must also have at least one claim for type 2 diabetes and at least one claim for an oral antidiabetic drug or the patient must have more claims for type 2 diabetes than for type 1 diabetes if no claims for an oral antidiabetic drug.

The approach will likely lead to product labeling that designates a drug for smaller patient populations.