leflunomide (lef), used for rheumatoid arthritis, inhibits dihydro-orotate dehydrogenase (dhodh) and tyrosine kinase (tk) enzymes and has anti-inflammatory, lymphocyte proliferation regulatory, immunosuppression and chondroprotective effects. the most common adverse effects are gastrointestinal disorders, weight loss, hypertension, skin infection, and neurological and hematological toxicity. it...

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative ...

The oseltamivir has also been recommended in Iran in the annex to the "National Guidelines for novel Coronavirus" and in the prime version of the Flowchart of Diagnosis and Treatment of COVID 19 at the outpatient and inpatient levels .The oseltamivir (Tamiflu) is a neuraminidase inhibitor that blocks the release of flu virus-laden droplets from infected cells in the respiratory tract. The oselt...

background: drug use evaluation (due) aims at improving the patients’ care. studying the administration pattern of intravenous immunoglobulin (ivig) is an important research topic due to its significant role in the treatment and controlling of many disorders, high prices, and limited availability of this drug. methods: this observational cross-sectional study was conducted at shahid sadoughi ho...

Since the passage of 21st Century Cures Act in 2016, The US Food and Drug Administration (FDA) has applied less stringent guidelines for new drug evaluations [1], resulting a decreasing number RCTs before approval [2].

Leflunomide (LEF), used for rheumatoid arthritis, inhibits dihydro-orotate dehydrogenase (DHODH) and tyrosine kinase (TK) enzymes and has anti-inflammatory, lymphocyte proliferation regulatory, immunosuppression and chondroprotective effects. The most common adverse effects are gastrointestinal disorders, weight loss, hypertension, skin infection, and neurological and hematological toxicity. It...

The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify...

The Food and Drug Administration (FDA) is requesting information and comments on the use of intraoral appliance (IOA) models as a substitute for the animal caries reduction (“rat caries models”) biological test required by the monograph for over-the-counter (OTC) anticaries drug products to demonstrate the availability of fluoride in OTC dentifrice formulations. This notice is part of the ongoi...