Pharma firms prefer to go with the existing brand names for new fixed dose combinations (FDCs) as it is easier to market them What’s in a name? A lot, according to pharmaceutical companies, many of whom have already launched or…
Half of EU Clinical Trial Results Not Reported
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…
Experts highlight Ebola vaccine progress and suggest next steps
Despite promising advances, important scientific questions remain unanswered in the effort to develop a safe and effective Ebola vaccine, according to members of an international Ebola research consortium. In a Viewpoint published in The Lancet, the experts review the current…
Mid 2018 – Recap of Warning Letters, Import Alerts and Non-Compliances
In our mid-2018 compliance review, we look at inspection challenges faced by companies across the world. In the first half of this year, manufacturing compliance challenges dominated headlines. But we also saw shortcomings at major pharmaceutical companies like Pfizer, Bayer…
New Report: Improving Clinical Site Payment Practices
Paying sites on time is critical to a trial’s success, sponsors agree, and most believe they’re making the grade. So why are sites so frustrated with how they’re paid? Are their expectations unreasonable or are sponsors operating in the dark?…
