FDA moves to block biopharma employees from serving on advisory committees
The FDA has issued a new directive barring employees of FDA-regulated biopharma companies from serving on its advisory committees to reduce perceived industry influence and promote greater transparency, while still allowing them to present views and contribute in limited circumstances.
FDA cuts outlined in draft HHS budget
The Trump administration's draft HHS budget proposes an 18.6% cut to FDA congressional funding and broader reductions across the agency, raising concerns about the FDA's operations and potential impacts on drug and device development, though analysts note Congress may ultimately restore much of the proposed funding.
Battling Outdated Regulations in the Trial Master File Space
In this video interview published by Applied Clinical Trials, Rob Jones product manager, TMF practice area, Pharmalex, discusses challenges the trial master file space is currently facing and how it can utilize collaboration in making advancements.
Analysis Reveals Polypharmacy Challenges in Patients With Cancer
A study published in Supportive Care in Cancer found that cancer patients in palliative care take an average of two unnecessary medications, contributing to pill burden and reduced quality of life. The study authors highlighted the effectiveness of pharmacist-physician collaboration, especially through direct communication, in safely deprescribing to improve patient outcomes.
Expert Discusses Transparency and Education for the Current Measles Outbreak
Crystal Hodge, PharmD, emphasizes the importance of transparency, data-driven communication and pharmacist-led education to combat measles outbreaks, address vaccine hesitancy, and rebuild public trust through informed consent, community engagement, and collaboration with health departments.
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.