Prahsant Kumar Data integrity issues have plagued manufacturing sites in India for several years. Repeatedly GMP sites in India were found in violation of documentation practices, data manipulation, data omission, and other issues that raise major issues about reliability of data. Although sites in India are not alone in data integrity issues but arguably sites in India received … Read more
A recent report based on a survey of about 1200 physicians provides a critique on how little prescribers know about the process of drug approval by the FDA. According to the report about 90% of the physicians surveyed could not correctly answer all three questions asked about FDA approval process. The survey asked two sets of questions; … Read more
It is well known that the most challenging aspect of running a given clinical trial is finding patients to participate in it. The main reasons are negative public perception of clinical trial participation, poorly designed clinical protocols and lack of planning by the clinical trial managers. And regulators are trying to help change that. Last … Read more
Regenerative medicine was identified as one of the top priorities for the US government in a report from the Subcommittee for Advanced Manufacturing of the National Science and Technology Council that advises the US President. The report acknowledged that cell-based medicine holds great potential to address critical medical issues related to cells, tissues, and organs particularly in … Read more
Last month in a rare bipartisan move, a new bill was introduced in the Congress to provide conditional approval to regenerative medicine products intended primarily to affect how FDA regulates the Human Cell, Tissue or cellular or tissue-based Products (HCT/Ps). The proposed bill, called the “Reliable and Effective Growth for Regenerative Health Options that Improve Wellness”, or … Read more
Genetic tests indicating risk of diseases based on genetic markers have gained in popularity and consumer acceptance over the last decade although regulators have frequently questioned the accuracy and clinical benefit of such tests. Genetic tests on otherwise healthy individuals to look for genetic markers and predicting the likelihood of getting a given disease are … Read more
March 2016 will likely be known for a myriad of actions taken by the US government to deal with drug overdose caused by prescription painkillers. First CDC released a new guideline for doctors who prescribe painkillers, followed by two new guidance documents by FDA, one adding a new black-box warning on all opioid painkillers, and … Read more
The breakthrough therapy designation (BTD) has been lauded as one of the most innovative of regulatory pathways as it modifies the conventional drug development, review and approval processes to speed up availability of new drugs to the patients. Since its implementation in 2012, more than 100 drugs have obtained this designation and already 39 new drugs have … Read more
FDA and CDC took several major steps this month to address abuse of prescription opiates. Opiate abuse is a major healthcare issue and has been termed a “crisis” and an “epidemic”. A detailed action plan was announced by FDA last month, one of the first major actions by the new FDA Commissioner. Abuse or Overdose accounts for about … Read more
Since the 2013 DOJ ruling against the Indian generic manufacturer, Ranbaxy, Indian manufacturers have been constantly in the news for all the wrong reasons. Although India is home to one of the World’s largest generic drug and API manufacturing industry with about 700 FDA-approved manufacturing facilities, the general impression is that Indian regulations are lax, and … Read more
