Regulatory Affairs, SaMD & Digital Health Expert
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 …
The Curious Case of Pharmaceutical Ads in the U.S. Pharmaceutical ads in the U.S. draw strong reactions—some people find them annoying, others absurd. Interestingly, the U.S. is one of only two high-income countries that allow these direct-to-consumer ads, the other being New Zealand. So, what gives? Why haven’t we put a stop to these ads? …
Tackling Deceptive Drug Advertisements: A New Push for Transparency The pharmaceutical advertising landscape is changing. Recently, President Trump instructed Health Secretary Robert F. Kennedy Jr. to take action against misleading direct-to-consumer drug ads. This decision comes at a time when the Food and Drug Administration (FDA) is stepping up its enforcement against deceptive advertising practices. …
FDA’s Upcoming Meeting on Digital Health: What You Need to Know Key Takeaways: The FDA will hold a virtual meeting for digital health advisors on November 6. This meeting aims to address challenges related to AI and tech regulation in healthcare. Agenda details and discussion questions will be shared closer to the meeting date. On …
Are FDA Expert Panels Jeopardizing Public Trust? The Food and Drug Administration (FDA) is a cornerstone of public health in America, guiding crucial decisions that affect our lives. However, recent developments raise serious concerns about how the agency is operating. In recent months, the FDA has started using ad-hoc “expert panels” for important decision-making processes …