The general quality expectations for clinical trials are described in a new ICH guidance adopted by the FDA this week. The concept of Quality-by-Design (QbD) has been the gold standard for defining quality expectations in manufacturing operations but similar standards lack for the conduct of clinical trials. It is generally accepted that the quality of … Read more
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
