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Regulatory News

In Pharma Industry Regulation section of PharmProm.Ru we cover latest Pharma News, Pharmaceutical Industry articles, Pharma Journals, Pharmaceutical articles and more.

Regulatory News

Recommendations on registering medical devices in EAEU adopted

Techno -
On December 23, the Eurasian Economic Commission's Board meeting adopted the Methodological Recommendations on the content and structure of the documents of the marketing...
Regulatory News

The EEC Collegium approved amendments to the rules for determining OTC categories of medicines

Techno -
According to the source, the general criteria for classifying drugs as OTC have been supplemented with special criteria for individual active substances.
Discovery and Development

Rules of import and export of biomaterials produced during clinical trials of drugs become effective in Russia

Techno -
Rules of import and export of biomaterials produced during clinical trials of drugs become effective in Russia from September 1 and will expire on...
Regulatory News

FDA approves Sanofi’s Dupixent for widespread use in the United States

Techno -
Sanofi won expanded U.S. approval for its best-selling Dupixent injection to treat an allergic inflammation of the esophagus, the Food and Drug Administration said...
Regulatory News

U.S.FDA lifts ban on COVAXIN Covid-19 vaccine candidate study

Techno -
Ocugen, Inc., a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, May 23th announced that the U.S. Food...
Regulatory News

MicroGEM’s PCR test, which gives results in 27 minutes, received EUA approval from FDA

Techno -
MicroGEM has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which...
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