iwewlkws Last month, FDA issued a Warning Letter to a California medical foods company, Targeted Medical Pharma (TMP), for conducting clinical trials without an IND. This is an interesting case study that highlights common regulatory issues with most companies doing clinical trials, and more specifically medical food and supplement developers. First, FDA regulates products based on … Read more
FDA does not treat most healthcare related smart-phone apps as medical devices, leaving it to the FTC and state regulators to regulate apps based on claims and complaints. Healthcare apps, mostly hosted on Smartphones, smart watches and other wearable devices, are popular due to high acceptance by consumers and seemingly endless possibilities. Apps can be … Read more
On 21 March 2017, the State of Arizona became the first state to pass the “Free Speech in Medicine Act” which allows manufacturers to practically discuss all kinds of off-label information with doctors and healthcare providers, without fear of prosecution. The day after, a similar bill, “Medical Product Communications Act, 2017”, was introduced in the … Read more
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
