iwewlkws Often you see a scientific article being touted in the news for its sensational findings. Journals make news releases, authors give interviews to news outlets, newspapers headline the findings, and pundits discuss what it means for everyone. However, an independent analysis of such articles found that less than half of the publications promoted on newspapers … Read more
This week the Office of Generic Drugs (OGD) released its annual report touting another year of record approvals of generic drugs. Almost 800 new generic drugs were approved last year by the OGD and just about half of them come from manufacturers based in India. Indian generic manufacturer had more approvals than even those located … Read more
In the recent days, FDA has come under constant attack for being “slow and burdensome” by none other than its own boss. The anecdotes have the risk of becoming mainstream when at the first address to the joint session of the Congress; the President uses a false case to demonstrate how the FDA process is … Read more
There is significant lack of diversity in clinical trial populations. FDA approved 67 new drugs in 2015 and 2016, and of the total trial populations, 5-7% were African-Americans, 11-12% were Asians, while 76-79% were White. Women were more equally represented with about 40-48% study populations being female. The situation was worse in certain indications like … Read more
Recently “Right to Try” bills were introduced in the US Senate and Congress. Similar laws have been enacted in 33 states; however it was felt that creating a Federal law will have a stronger impact in getting companies to give experiment drugs to terminally ill patients. While the intent behind the bills is great, the … Read more
Adverse event monitoring in clinical trials can be automated and revolutionized using wearable medical devices as indicated by a recent study. The study showed that data collected using wearable devices to monitor physiological changes can be exploited to identify illness and other changes in health status over time. There are no surprises here but this … Read more
Most discussions about data integrity revolve around misconduct by sponsors and CROs. An often silent topic is fraud by patients participating in trials. Recently there were reports of extensive fraud by subjects participating in Phase 1 clinical trials in China. Subjects would routinely manipulate biological samples, use fake IDs to get around recruitment restrictions, and … Read more
Peer-reviewed publication of clinical trial results, expert opinions and patient advocacy groups are frequently used to support market approval of drugs and public policy discussions. A series of articles published last week raise serious questions about the conflict of interest issues in such information. Major aspects of public discussions involving new drugs may be tainted … Read more
Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, … Read more
A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and … Read more
