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“DCGI has made it mandatory for all manufacturers and importers who have obtain new drug permission to submit Periodic Safety Update Reports of new drug every six months for the first two year and...

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G.S.R. 588(E) – whereas certain draft rules further to amend the Drugs & cosmetics Rules, 1945, were published, as required by sections 12 and 33 of the drugs & cosmetics act, 1940...

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The success of any new drug or FDC largely depends on the rationale and justification for using it. In line with the new regulations at CDSCO, all cases of new drugs, FDCs,...

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New Rules for Clinical Trials and Drugs Promote Research and Ensure Patient Safety

Physicians applaud the latest step in reducing new HIV cases, but insist that high-risk individuals who take the medication still need to practice safe sex. After decades of health professionals trying to...

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We expertise in preparationof: Manuscript Writing / Editing Conference Abstracts / Presentations Content, Design and Layout of Scientific Posters Journal Selection / Submission Editorial Writing Product Monograph Patient Information Leaflet Summary of...

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The requirement of local trial for a generic or similar biological (Bio- Similar) in other country like USA for its approval in the country, it has been decided that the drugs considered...

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