Drug regulatory actions

After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany.

10p vimontana2711 05-04-2021 12 2   Download

Regulator of G-protein signaling (RGS) proteins were originally identified as negative regulators of G-protein-coupled receptor (GPCR) signaling via their GTPase-accelerating protein (GAP) activity. All RGS proteins contain evolutionarily conserved RGS domain; however, they differ in their size and regulatory domains. RGS1 and RGS10 are smaller than other RGS proteins, and their functions involve various inflammatory responses including autoimmune responses in both the periphery and the central nervous system (CNS). Neuroinflammation is the chronic inflammatory response in the CNS.

5p caothientrangnguyen 09-05-2020 22 1   Download

When a new veterinary medicinal product is launched into widespread use, adverse drug reactions may become apparent. These may be seen in the treated animal patients, in exposed users or as adverse effects on the environment. Additionally, they may manifest as excess residues of the drug in food of animal origin. As a consequence, legislation and regulatory approaches have developed across the globe to address these issues and to ensure that the continued safety of these products can be monitored and, where necessary, that regulatory actions can be pursued to assuage any concerns.

779p mnemosyne75 02-02-2013 60 7   Download