Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far. The analysis, led by University of Oxford researcher…
Clinical Trials: There’s an App for That
When Apple introduced the latest iteration of its Apple Watch earlier this month, it was hailed by an unlikely source: FDA Commissioner Scott Gottlieb. “The FDA worked closely with the company as they developed and tested these software products, which…
Global Regulatory & Consumer Insights company, Announces Strategic Collaboration Agreement with Indian Institute of Technology – Bombay
Cancer therapeutics currently have the lowest clinical trial success rate of all major diseases. Partly as a result of the paucity of successful anti-cancer Medical Devices, cancer will soon be the leading cause of mortality in developed countries. Global Regulatory…
Prohibition and restriction of manufacture, sale and distribution of Fixed Dose Combinations (FDCs)
The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution…
RE-NAMING OF INDIAN REGULATORY AGENCY (CDSCO)
Central Drugs Standard Control Organization (CDSCO) is the national drug regulatory agency under the Ministry of Health and Family Welfare, Government of India. Over the years, the role of CDSCO has expanded to several areas, for the same the Drugs…
Each saleable unit of the new drug shall accompany by the package insert
Ministry of Health [MoH] is proposing amendment to Form 45 and Form 46 to make it mandatory that ‘each saleable unit of new drug should be accompanied by package insert for providing to the consumer’. Draft notification has been issued…