Sentence examples for regulatory classifications from inspiring English sources

The prevalence of HSCT makes it an ideal case study to prepare for more complex biological manufacturing with more challenging regulatory classifications.

In the closing presentation, Fred Degnan (King & Spalding, LLP) discussed the perspectives of the U.S. FDA on clinical study requirements as it relates to regulatory classifications for probiotic-containing products.

A potential probiotic product can fall along a continuum of regulatory classifications, each having implications on the nature and degree of regulatory requirements for clinical research and, ultimately, for claim substantiation and market access.

Late last month, the federal Drug Enforcement Administration suspended Dr. Talley's license to prescribe controlled substances, a regulatory classification that includes narcotics like OxyContin but not more commonly used drugs like penicillin.

The debate over the proper regulatory classification and treatment of broadband internet access is neither new nor novel.

We are determined to foster a conversation that ensures safety and efficacy for a large number of medical models, and to group these models with respect to risk, which may correlate to the regulatory classification associated with specific applications.

Therefore, we suspect that with more detailed experiments, further regulatory classification is possible.

Such products would fall under the FDA regulatory classification of combination devices, which have their own regulatory requirements before clinical acceptance [ 70].

In determining whether an IND application is required before a clinical study may lawfully commence, investigators and researchers as well as institutional review boards should consider the regulatory classification, e.g., "drug," "new drug," "food," "food additive," "dietary supplement," etc. that applies to the substance under investigation.

The majority of treatment-emergent adverse events (incidence of >3%) were respiratory events, in particular COPD exacerbations and infections according to Medical Dictionary for Regulatory Activities (MedDRA) classifications.

AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) classification.