A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...

The International Pharmaceutical Excipients Council (IPEC) has just released a how to guide to assist the pharmaceutical industry in complying with new labeling and reporting rules for microplastics that have been intentionally added to pharmaceuticals.   The document “summarizes the core elements of the restriction proposal and intends to provide guidance for excipient manufacturers and users on how to prepare for compliance,” IPEC announced.   The microplastics...

The delayed Clinical Trials Regulation (CTR) is set to take effect on Monday, 31 January, marking a milestone in the European Union’s attempt to improve transparency and boost the amount of human research that takes place in the region.   Currently, sponsors must file clinical trial applications to national regulators and ethics committees in each country that they want to include in their studies, then cope with multiple processes for registering their studies and pos...

Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might be necessary to reliably get results from these trials in a timelier manner.   Robert Califf, head of clinical policy and strategy for Verily and Google Health and the Biden Administration’s nominee to be FDA commissioner, said a legisla...

Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them in a single “umbrella” trial.   The draft guidance, released in September 2021, outlined FDA’s proposed thinking for how this process would work. For cell and gene therapies intended to treat a single disease, sponsors would typically ...

The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...

The European Medicines Agency (EMA) recently released a report that reflected on a decade of implementing a framework to better work with doctors, pharmacists, and nurses in the EU.   As of December 2021, there are now 38 eligible organizations working with the agency in a variety of practice areas. The framework is designed for EMA to access a network of independent experts in clinical practice who can advise on real-world experience with drug development, benefit-ris...

The European Commission has issued rules outlining the circumstances in which medical device instructions for use (IFU) can be provided in electronic form, rather than in paper form.   The implementing regulation , issued on 14 December, brings the European Union into alignment with device regulators in the US, Australia, and other nations, which already allow electronic labeling/IFU for certain medical devices. (RELATED: TGA Offers Guidance on Electronic Instructio...

  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...

This article discusses pediatric drug development in the EU and US, with an emphasis on overcoming regulatory obstacles. The authors present the commonalities and differences between US and EU regulations and guidelines and examine the legislative acts and subsequent regulatory requirements, while outlining the necessary steps for successful implementation of pediatric drug clinical trials. They conclude with a discussion of three case studies that highlight strategic init...

A commission ordered by the EC Directorate-General for Health and Food Safety (DG SANTE) to conduct a study on medicine shortages in the EU and European Economic Area (EEA) has released a final report outlining the problem and its recommendations for stakeholders.   Documenting the scope of human medicine shortages in EU/EEA countries between 2004 and 2020, the study conducted by Technopolis Group, Milieu Law & Policy Consulting and Ecorys analyzed data from 22 differe...