Global Regulatory

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Global Regulatory
July 10, 2018

Alexey Stepanov recently represented an update on medical device regulations in Russia, Eurasian union and Kazakhstan. The medical devices are an integral part of treatment.

8min read    
News
Global Regulatory
July 10, 2018

Tofacitinib Citrate, an FDA approved Janus kinase (JAK) inhibitor recently obtains marketing approval from the European Commission (EC) to treat psoriatic arthritis (PsA) among patients who show poor reactions towards DMARD treatment. Before this event, Tofacitinib Citrate along with MTX got approval in EU for treating rheumatoid arthritis. Tofacitinib Citrate is licensed in about 80 countries for managing psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In Europe, Tofacitinib Citrate approval is a breakthrough event as PsA affects between 1.5, and 3 million people yearly in this continent.

5min read    
News
Global Regulatory
July 9, 2018

The Food and Drug administration recently approved lipogems as a reparative approach in arthroscopic and orthopaedic surgeries. Lipogems is a cell revitalization technology, which utilizes patient body's fat cells for the renewal of damaged cells. The approach is well suited for all the age groups, from a child to an elder and from young to professional athletes. These days, patients are looking for novel treatment alternatives to other invasive treatments, and for them, fat cells are the most suitable as they can be derived from the patient’s own body. Liposomes is the best choice of treatment for those patients who have already undergone treatment with steroid injections, physical therapy, NSAIDs drugs and other in-efficacious drugs.

8min read    
News
Global Regulatory
August 21, 2017

The Food and Drug Administration declared that it would require strong new warnings that the combined use of opioid medications and benzodiazepines, a class of anti-anxiety medications can dangerously suppress breathing and cause coma or death. Thus, the stronger warning is required just to ensure the public that the combination can be dangerous.

FDA
4min read    
News
Global Regulatory
August 21, 2017

FDA announced that the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM). OCOMM has established a new “Drug Safety Labeling Changes (SLC)” database that provides these data to the public in downloadable and searchable formats.

FDA
4min read