Sentence examples for usa fda from inspiring English sources

For example, recent legislation has provided the USA FDA with a new breakthrough therapy designation that offers the possibility of accelerated approval for investigational new drugs for serious conditions[54].

In this model, governmental regulatory offices (e.g., USA: FDA, EU: EMEA) act as gatekeepers.

This analytical method has been validated according to USA FDA guidelines.

As stipulated by USA FDA guidelines, quality control samples at low, middle and high concentration were analyzed within each analytical batch to ensure accuracy and precision during analysis.

After approved by the Food and Drug Administration of USA (FDA) in 1998, infliximab has been used for IBD treatment for about 15 years, and its clinical efficacy has been well studied.

In the USA, FDA in September 2010 issued a requirement that patients be screened for CKD prior to undergoing GBCA-enhanced MR scans and issued a contraindication against administering linear-chelated GBCAs to CKD patients [ 27].

Hybrid Capture 2 (HC2) is the first USA FDA-approved HR-HPV DNA test.

As procedure of ELISA-based cross-matching, the Antibody Monitoring System (AMS) class I/II ELISA (GTI, Waukesha, USA, FDA-number BK 060038 from June 26 , 2006 was first implemented by us until its discontinuation in 2013 when it had to be replaced by the alternative AbCross HLA class I/II ELISA (Biotest/BioRad, Dreieich, Germany).

Sections were scored semi-quantitatively according to the following USA FDA-approved scoring system (Jacobs et al, 1999): 0, no immunostaining; 1+, complete membranous immunostaining of <10% of tumour cells; 2+, weak complete membranous staining of >10% of tumour cells; 3+, strong complete membranous staining of >10% of tumour cells.

To date, the most comprehensive published study is a randomized, double-blind, sham device-controlled clinical trial of 110 male subjects showing that the HairMax Lasercomb® (Lexington International, LLC., Boca Raton, FL, USA), FDA-cleared to treat pattern hair loss in male subjects at the time, was effective in increasing terminal hair density after 26 weeks of treatment [ 8].

CEL files exported from GCOS were uploaded into ArrayTrack software (National Center for Toxicological Research, U.S. FDA, Jefferson, AR, USA (NCTR/FDA)) and normalized using Total Intensity Normalization after subtracting backgrounds for data management and analysis.