Regulatory Affairs, SaMD & Digital Health Expert
I like to write about people, the places they live and the things with which they choose to surround themselves. Here are some of my favorite pieces that made it into Article.
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 …
Key Takeaways America is at a crucial point in advancing science and public health. Changes in the drug development process can accelerate patient access to lifesaving therapies. The FDA’s new PreCheck program is designed to streamline drug manufacturing and approval. Industry collaboration is essential for improving the pharmaceutical supply chain. Modernizing regulations can transform how …
Key Takeaways Crinetics Pharmaceuticals received FDA approval for Palsonify, a new treatment for acromegaly. The drug is considered safe and effective, lowering growth hormone levels significantly. Palsonify is aimed at adults who cannot undergo surgery or didn’t respond to it effectively. The annual cost for Palsonify will be approximately $290,000. Crinetics views this approval as …
Key Takeaways: The FDA has reapproved GSK’s Wellcovorin, a drug discontinued over 25 years ago. This move is part of a broader initiative to explore treatments for autism, supported by the Trump administration. The drug is related to leucovorin, which helps mitigate side effects from cancer therapies. Concerns were raised about Tylenol use during pregnancy …
Key Takeaways: The FDA plans to stop using external expert panels for reviewing drug applications. This change aims to streamline the evaluation process and shift focus to larger issues. Critics are concerned about reduced public scrutiny and transparency in FDA decisions. In recent news, the FDA is considering a significant shift in how it reviews …
Key Takeaways Federal regulators issued around 100 warning letters to pharmaceutical companies and healthcare providers. The letters targeted misleading advertising practices from major drugmakers and telehealth companies. Experts question if the FDA has enough resources to effectively follow up on these warnings. Understanding the Recent FDA Action on Pharmaceutical Advertising In a surprising step, federal …