iwewlkws The 505(b)(2) regulatory pathway is primarily designed to get FDA approval of new indications of previously approved products. A provision in the 21st Century Cures Act, that became the law this week, could create a promising expedited approval pathway for 505(b)(2) products. Developers of such products need to conduct randomized clinical trials (RCTs) for the new indication. The … Read more
This week FDA released a comprehensive list of all adverse events (AEs) reported to it related to food, dietary supplements and cosmetics for the last 12 years. This information was previously available only upon freedom of information request. The announcement “Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics … Read more
Regenerative therapies are set to receive renewed attention and attractive regulatory incentives thanks to the 21st Century Cures Act (Cures Act) which is all but certain to become the law this week. The new law defines “regenerative medicine therapy” to be cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or … Read more
No one knows what President Trump would do next but we can certainly wish that the new perspective would possibly resolve a few issues that have challenged pharma-FDA relations for the last few years. There have been major disagreements over the rigid interpretation of regulations by FDA. Yesterday, the US Congress passed the 21st Century Cures … Read more
In the last few years, the drug manufacturing technology has been going through steep modernization. Some developments are simpler and logical such as use of single-use systems, while others are more complex such as 3D-printed drugs, continuous manufacturing systems, and robotic manufacturing systems. Manufacturers need additional help from FDA to assure continued compliance. Recently FDA created … Read more
What is the most productive age of an individual? Who is going to be more creative? Age-based discrimination in hiring practices is the most common reason for individuals being denied job opportunities, particularly when changing careers. Does the potential of individuals to do high-impact work depend on their age? Are younger workers more productive than … Read more
Last week senior officials at FDA, including the FDA Commissioner, spent two full days listening and discussing their policy on regulation of off-label claims with stakeholders. The net result, no clear consensus and ongoing confusion about what the FDA may do next. About 70 speakers representing pharma and biotech companies, patient groups, industry lobbyists, and individuals presented a wide … Read more
Rapid information exchange using Twitter is getting increasingly popular among scientists for sharing articles and data leading to interesting outcomes as highlighted in a case presented in The Scientist. Genomics researchers attending a conference in Cambridge, UK, found out through a tweet that researchers from the Beijing Genomics Institute had publicly just released an unassembled sequence … Read more
In an obligatory article on the shocking presidential election results, let’s discuss the expected affect of the political upheaval on the pharma industry. It is purely speculative as nobody can say with authority what President Trump would do. The politics of the time does affect the regulatory environment. The good things first. Last eight years … Read more
Bias in clinical trial results is often suspected, particularly when the studies are not independently reviewed by regulators. Clinical studies are often conducted for marketing purposes with non-FDA regulated products such as food and supplements. In a review of clinical studies conducted to evaluate the link between consumption of soda and occurrence of obesity, it was found … Read more
