Regulatory Affairs, SaMD & Digital Health Expert
FDA’s New Priority Review Voucher Program: What You Need to Know The Food and Drug Administration (FDA) is revamping how it reviews drugs, and Commissioner Marty Makary wants to speed things up. One of the latest initiatives is a new priority review voucher program launched in June. This program is all about finding innovative ways …
Telehealth Boom: Exploring the Benefits and Challenges TL;DR: The COVID-19 pandemic accelerated the adoption of telehealth, bringing numerous benefits such as increased accessibility, convenience, and cost-effectiveness. However, it also presents challenges including privacy concerns, technology access disparities, and the need for quality assurance. Understanding these aspects is crucial for anyone interested in the evolving landscape …
Key Takeaways: The FDA is experiencing significant changes affecting drug approvals. Drug approval rates have dropped from 87% to 73% in the last quarter. Rejections of marketing applications surged to 15%, higher than the typical 10%. Review delays for applications increased to 11%, compared to an average of 4%. The recent shake-up at the Food …
Key Takeaways Eli Lilly’s recent hiring of a former FDA official raises questions about potential conflicts of interest. Critics worry that such moves could undermine public trust and decision-making at the FDA. Eli Lilly’s chief scientific officer argues that industry involvement can enhance medicine development and contribute positively to society. In the world of pharmaceuticals, …
Key Takeaways Replimune and Capricor Therapeutics face significant delays in FDA drug approvals. Leaders emphasize the need for a consistent and transparent FDA for drug development. Uncertainty at the FDA could hinder the development of innovative treatments. Navigating Drug Approval Challenges In the biotech industry, getting a drug approved is no small feat. For companies …
Understanding the FDA’s Bold Move on Leucovorin for Autism Treatment In a surprising turn of events this past August, the FDA found itself at the center of an unusual inquiry regarding leucovorin, a generic drug primarily used for managing the side effects of cancer treatments. The leadership at the FDA is now exploring the possibility …
Understanding Clinical Trials: The FMLA’s New Impact on Patients When faced with a diagnosis of a complex disease like sarcoidosis, patients often confront overwhelming decisions. A patient of mine had to choose between taking steroids or enrolling in a clinical trial. She chose the trial, hoping for better treatment options. However, as the trial unfolded, …
Peter Marks Takes on New Role at Eli Lilly: What It Means for Public Health Former FDA vaccine chief Peter Marks has moved to Eli Lilly. This role focuses on molecule discovery and infectious diseases. His transition raises concerns about the revolving door between government and industry. Marks expresses excitement about contributing to public health. …
New Approval for Generic Mifepristone: What It Means for Abortion Access The recent approval of a new generic version of the abortion pill mifepristone by the Food and Drug Administration (FDA) has sparked significant reactions, both supportive and critical. This move could impact access to abortion services across the U.S., especially as debates about reproductive …
Key Takeaways FDA regulator George Tidmarsh raised alarms about the lupus drug voclosporin. He highlighted concerns over the drug’s toxicity and lack of clinical benefits. Tidmarsh’s comments sparked speculation about personal motivations behind his statements. Is There a Personal Grudge Behind FDA Comments on Voclosporin? Have you ever had a situation where a colleague made …