This week European Medicines Agency (EMA) announced suspension of the approval of 331 drugs due to gross data integrity violations at an Indian CRO. This is the third episode of its kind in the last 2 years and exposes a major defect in the regulatory review process in EU. One wonders how the CROs managed … Read more
The FDA’s Office of Regulatory Affairs (ORA), which is responsible for all audits conducted by FDA, is undergoing a major reorganization starting 17th May this year, which is expected to dramatically change how FDA audits. ORA will distribute its auditors into five specialized commodity-based groups, plus one group for clinical trial audits. This is radically … Read more
A recent study by the Tuffs Center for the Study of Drug Development indicates that on an average the 505(b)(2) NDAs take about 5 months longer to get approval from the FDA compared to the new molecular entities (NMEs). However, this is an incomplete story. The authors of the survey specifically looked at the time … Read more
Manufacturers of cell therapy products deal with several practical, logistical and scientific limitations much different from other biologic and drug products. Taking that into consideration, last year European Commission’s Directorate-General for Health and Food Safety (DGFHS), the governing body for the European Medicines Agency (EMA), released a draft guidance aiming to create special standalone rules … Read more
This week Dr. Scott Gottlieb was nominated to head the FDA. Dr. Gottlieb has a very interesting resume. He was the Deputy Commissioner at FDA, followed by working at political think-tanks and a very active investor in FDA regulated companies, so obvious questions about conflict of interest may arise at his confirmation. The confirmation of … Read more
This week FDA announced its plans to open a new Office of Patient Affairs (OPA) to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. However, how will this office impact regulatory decisions is not clear. According to the notice in the Federal Register, this idea came about … Read more
US hospitals are increasingly selling alternative medical treatments, which have not been approved by FDA and are considered unproven therapies, to their patients. Many well-established large hospitals have created spas to offer acupuncture, Reiki, homeopathy, energy treatments, naturopathy, herbal medicines, supplement therapy and several other forms of alternative treatments that previously were frowned upon by … Read more
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
