The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting.

Purpose: The COVID-19 pandemic has affected the management and operation of regulatory agencies and the pharmaceutical industry around the world. It has prompted regulatory authorities to consider new ways of working and introduced, among others, remote inspections to validate the integrity of the regulatory data submitted by companies, to evaluate the quality of production and manufacturing sites, and to ensure the conformity with Good Regulatory Practices with the overall goal of guaranteeing patient safety during the crisis.

Method: This article summarizes and discusses remote inspection guidelines and other related information made available by the Therapeutic Goods Administration (Australia), the European Medicines Agency (EMA), the Pharmaceutical and Medical Devices Agency (Japan), the Medicines and Healthcare Products Regulatory Agency (United Kingdom), and the US Food and Drug Administration (FDA).

Local differentiation amidst extensive allele sharing in Oryza nivara and O. rufipogon.

Genetic variation patterns within and between species may change along geographic gradients and at different spatial scales. This was revealed by microsatellite data at 29 loci obtained from 119 accessions of three Oryza series Sativae species in Asia Pacific: Oryza nivara Sharma and Shastry, O. rufipogon Griff.

Does topical lidocaine before tracheal intubation attenuate airway responses in children? An observational audit.

Background: The use of topical lidocaine, applied to the airways with various administration techniques, is common practice in pediatric anesthesia in many institutions. However, it remains unclear whether these practices achieve their intended goal of reducing the risk of perioperative respiratory adverse events (PRAE) in children undergoing elective endotracheal intubation without neuromuscular blockade (NMB). The relative frequency of PRAE (laryngospasm, coughing, desaturation <95%) associated with no use of topical airway lidocaine (TAL), with TAL sprayed directly onto the vocal cords, and TAL administered blindly into the pharynx was assessed.