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Manufacturers of breakthrough therapy (BTD) products often face challenges meeting all the CMC requirements for the NDA/BLA for their product. Similar issues are faced by those developing new products under the PRIME program in EU. This week the regulators published a detailed discussion using case studies on how manufacturers can satisfy regulatory requirements in the … Read more

An editorial in the British Medical Journal provides one of the first clinical perspective on smartphone based basic healthcare from a large real world data. Patients in London were provided a smartphone app-based algorithm, called GP at Hand, where almost all initial contacts between patients and physicians were through smartphone consultations, with the patients having … Read more

This week FDA issued a detailed Warning Letter to one of the country’s most prolific sellers of CBD products, Cureleaf. The Cureleaf Warning Letter lists numerous violations of the drug laws namely in the lofty and mostly dubious claims made by the company for its CBD products and false attempts to label their products as … Read more

A recent study reported that almost 90% of diagnostic errors cases are attributed to errors in clinical judgement by physicians in outpatient settings. These findings have a strong implication for developers of AI algorithms to automate diagnosis aiming to reduce human errors. Common clinical judgement errors are delayed ordering of diagnostic tests, failure to review … Read more

As of last week, FDA has fully implemented its Mutual Recognition Agreement (MRA) with the European Union (EU) whereby FDA and regulators from all 28 member countries of the EU would share GMP inspection findings at drug manufacturing sites. The MRA is but the first step to integrating GMP audits across various regulators to avoid … Read more

Should FDA officials be restricted in what jobs they can pursue after leaving office? A few days after leaving the FDA, the last Commissioner Scott Gottlieb joined the same venture firm he left to join FDA. Then a few weeks later he joined the Board of Pfizer. In that he joined the long tradition of … Read more

Three out of four new drugs approvals by FDA use expedited approval pathways making faster than normal review by FDA the normal process compared to it being used only for exceptional cases about 10 years ago. Also, more than half of the new drugs approved by FDA are for life-threatening diseases and unmet medical needs. … Read more

A prominent blog this week speculated why India seems to be becoming an attractive place for developers of Artificial Intelligence (AI) based medical technology. India offers some obvious advantages to developers over other countries in the region, however, one must consider some important lessons from the recent history of the clinical trial industry in the … Read more

Most clinical trials struggle to recruit diverse populations. Use of Real World Evidence (RWE) may offer the solution to this problem. Despite active encouragement and a few guidance documents from FDA about the importance of diversity in clinical trial populations, almost all the new products approved by the FDA in the last decade were based … Read more

A study released this week reported that common home-based smart listening devices like Amazon Echo and iPhones could be used to detect cardiac arrest based on irregular breathing sound. The authors show how everyday common devices can be used not only to detect cardiac arrest with a greater than 97% sensitivity and specificity but that … Read more