The US Food and Drug Administration’s (FDA) advisory committee system needs to be changed to allow fuller and more comprehensive discussion of the issues surrounding the approval of a medical product under review and should be less about the outcome, said FDA Commissioner Robert Califf.   Califf made these remarks at the Biopharma Congress meeting in Washington, DC on 13 February. During the meeting, which was moderated by Kate Rawson of Prevision Policy, Califf also r...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Rejects Soligenix’s Lymphoma Candidate ( BioSpace ) ( Reuters ) ( Endpoints ) ( Fierce ) OTC Naloxone In US Could Limit Access Due To Costs, Comments On Emergent Switch NDA Argue ( Pink Sheet ) FDA rejects Biocon and Viatris' Avastin biosimilar after inspection question marks ( Endpoints ) Scientific institutions must embrace antiracist policies, National ...

A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program developed for cell and gene therapies, as the involvement of other “high-income countries” could help attract developers, asserted Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), at the Biopharma Congress on 13 February.   At the meeting, FDA officials offered their perspectives on other policy ar...

The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental studies to support the safety of drugs, biologics and devices used in neonatal populations. Such studies, said FDA “will help ensure a safer product.”   The guidance addresses factors for determining when it is necessary to conduct a long-term safety study, how to develop a safety study and what to measure in the...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently warned two foreign medical device companies – a manufacturer of microcatheters and a laparoscopic instrument maker – for issues including failing to follow through on corrective actions plans, not seeking necessary approval for a new device use and a lax materials testing program.   The targets of the warning letters, which were posted to FDA’s website on 7 February, ...

Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted that the duration of clinical trials for gene therapies depends on the nature of the disease being treated, and that diseases that are more progressive and have a rapid onset may involve shorter trials.   This was one of the learnings imparted by officials during a 7 February virtual town hall meeting to...

With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a guide to help drugmakers and their trading partners establish the necessary electronic systems to track their products through the supply chain.   The new chapters complement an earlier guide on understanding the compliance and baseline business requirements on trading of information, which was released in July 20...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA says India-made eye drop linked to some infections, blindness and one death ( Reuters ) ( Bloomberg ) ( IndianExpress ) Gilead’s Trodelvy Approved for More US Cancer Patients ( Bloomberg ) ( Reuters ) ( Endpoints ) Biogen’s $1.5B Bet for Depressive Disorders Heads to FDA ( BioSpace ) ( Fierce ) ( Endpoints ) ( STAT ) Bountiful Approvals May Be Ahead As FDA...

The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to participate in a new multistakeholder platform (MSP) or forum to share and implement ideas for improving clinical trials in the EU.   The call for participation is being launched under last year’s EC-HMA-EMA initiative Accelerating Clinical Tri...

The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs to treat the early stages of Lyme disease.   The draft addresses criteria for clinical trial enrollment, efficacy endpoints, and clinical microbiology considerations for treating early stages of the disease when manifested by erythema migrans (EM), a rash that is often one of the first symptoms.   In North America, Lyme...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Glaxo’s Jesduvroq as Oral Treatment for Anemia ( Reuters ) ( Endpoints ) COVID-19 tracker: Merck pill linked to new mutations, study says ( Fierce ) ( Bloomberg ) FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test ( Inside Health Policy ) ( Endpoints ) What Changes When the COVID Emergency Ends in May? ( MedPage Today ) Modern...

The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such as use data from registries and electronic health records, in lieu of data from randomized controlled trials (RCTs) to demonstrate the safety and effectiveness of new drugs and biologics.   The draft guidance also describes how sponsors can communicate with FDA on using dat...