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?…
Risk-Based Monitoring: Widespread Implementation is Underway, but Still Messy
The industry has been abuzz about risk-based monitoring (RBM) for much of the last decade, with the FDA indicating that it would like to see more sponsors give it a try. But in practice, many companies are only just beginning…
Encouraged by Regulators, Sponsors Begin Adopting Real-World Evidence into Clinical Trials
While the FDA is preparing to develop and implement a program evaluating the potential use of real-world evidence (RWE) for regulatory decision making, a panel discussion at this year’s DIA Global annual meeting described how the industry is already using…
Research Projects Show Credentialed Principal Investigators and CRCs Perform Better
The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. That was the thrust of the DIA session Assessing the Impact…
