Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. It’s been a busy week for the agency as Xavier Becerra, secretary of the US Department of Health and Human Services, defended his department’s proposed FY2024 budget in the Senate, the FDA released several guidances and reports, and announced upcoming meetings.   During a Senate Fin...

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process.   As part of FDA’s commitment under the Prescription Drug User...

BASEL, Switzerland – In a pandemic-like situation, the European Medicines Agency (EMA) should reserve resource-intensive activities for promising medicines and should reinforce its cooperation with partners such as the EU National Immunization Technical Advisory Groups (NITAGs). That’s according to the agency’s Melanie Carr, who spoke at DIA Europe 2023 on some of the knowledge EMA gleaned from the COVID-19 pandemic.   Carr, head of stakeholders and communications divi...

BASEL, Switzerland – Work is progressing to overcome the obstacles associated with European decentralized clinical trials and advance their adoption, regulatory and industry officials said during a panel session at DIA Europe 2023. An upcoming guideline from the International Council on Harmonisation (ICH) may soon boost these efforts.   At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed so...

The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to develop new products.   HHS Secretary Xavier Becerra discussed President Joe Biden’s FY2024 budget request for his department during a Senate Finance Committee hearing on 22 March. While lawmakers questioned him about reimbursement issues r...

BASEL, Switzerland – DARWIN EU is starting to collect more real-world data (RWD) and gain more adherents as an increasing number of regulators and industry groups recognize the value of RWD, Peter Arlett, head of the European Medicine Agency’s data analytics and methods task force, said at DIA Europe 2023.   RWD saw a significant boost from the COVID-19 pandemic, Arlett said. Pre-pandemic, when EMA recommended the establishment of the Data Analysis and Real World Inter...

The Medicines and Healthcare products Regulatory Agency (MHRA) has committed to embarking on the UK’s “biggest overhaul of trial regulation in 20 years” after a consultation revealed support for many of the draft proposals.   At the start of 2022, MHRA sought feedback on proposals to take advantage of the UK’s split with the EU and “deliver a world-class sovereign regulatory environment for clinical trials.”  The goals of the proposed legislative amendments included st...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna to Price Its Covid-19 Vaccine at $130 a Dose ( Wall Street Journal ) Delays in reporting led FDA to late cancer warning on breast implants, advocates say ( Medtech Dive ) Moderna CEO defends price of COVID shot at Senate hearing ( Healthcare Dive ) 'Banding together': 50 female biotech executives lay out plans for board diversity, new companies and men...

Welcome to the March issue of RF Quarterly, which examines patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; generating evidence for racial and ethnic minorities in oncologic drug development; structured, patient-focused benefit-risk assessment; and the role of the high-performance integrated virtual environment in research using patient-generated data....

Patient-reported outcome measures (PROMs) have been increasingly mandated to measure the success of clinical outcomes in regulatory decision making. However, these outcome measures require expertise in their application and interpretation to allow realistic assessment of the results. Published literature and guidances from the US Food and Drug Administration (FDA) can help with understanding how best these measures can be used in regulatory practice. Particularly, recent w...

This article compares real-world evidence (RWE) and postmarket surveillance (PMS) data collected outside of a randomized, controlled, clinical trial. Real-world data (RWD) include individual patient data points such as complaints and anecdotal findings. The recent explosion in RWD collection has led to new challenges in RWD evaluation globally. Solutions are rapidly evolving to analyze these relatively random data points for scientifically valid purposes. This article disc...

Discussions regarding diversity, equity, and inclusion in healthcare and clinical research have been ongoing for decades. However, the COVID-19 global pandemic brought about a new focus on this issue. As the pharmaceutical industry began strategizing on how to improve diversity in its clinical trials, the Reagan-Udall Foundation for the FDA in collaboration with the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence convened a series of interviews and ...