Seven years after its inception, the FDA has finalized its first guidance on the Voluntary Malfunction Summary Report (VMSR) program for medical devices. Read our analysis here: #AgencyIQ #Politico #LifeSciences #FDA #Regulation #MedicalDevices

Courtney Lias has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of Tim Stenzel at the end of 2023. Recently she confirmed she is now the permanent Director. Read our analysis: #AgencyIQ #Politico #FDA

ECHA has issued a new guide for NEAs, clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures. Read more: #AgencyIQ #Politico #Chemicals #ECHA

Over a year since its initial draft guidance document on the use of PCCPs for medical devices that leverage machine learning, the agency has issued a new draft guidance on the use of PCCPs for all medical devices. Read more: #AgencyIQ #Politico #CDRH

Don't miss out! Register here: to join us on tomorrow, Tuesday, August 27, at 12pm ET, for a free and informative webinar where AgencyIQ’s research team will discuss the what the FDA still has on its plate in 2024. #AgencyIQ #Politico #FDA #Webinar

On August 9, Lykos Therapeutics received a CRL from the FDA, stating the agency will not currently approve its application for MDMA to treat post-traumatic stress disorder. AgencyIQ unpacks the announcement here: #AgencyIQ #Politico #LifeSciences #FDA

That’s a wrap on the #DNC2024! POLITICO kicked off the convention with an exclusive event for @POLITICOPro, @EENewsUpdates, and @AgencyIQ subscribers. Throughout the week, our reporting team hosted VIP Convention Conversations with some of the nation’s most influential Democrats

The AgencyIQ team is excited to attend RAPS Convergence this September! Be sure to visit us at booth 708. Learn more about the event and access exclusive AgencyIQ content here: #AgencyIQ #Politico #Regulation #RAPS

The FDA has finalized its guidance on dose optimization for oncology products. AgencyIQ has combed through the final guidance document to tease out what’s new and what’s the same, read here: #AgencyIQ #Politico #LifeSciences #Regulation #FDA #Oncology

Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. Read the details here: #AgencyIQ #Politico #LifeSciences #Regulation #Regulatory #EMA

In its inaugural meeting, FDA’s Genetic Metabolic Diseases Advisory Committee heard Zevra’s second try for arimoclomol to treat ultra-rare lysosomal storage disorder Niemann-Pick Type C. Read the details here: #AgencyIQ #Politico #Regulation #FDA

The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). Read the details here: #AgencyIQ #Politico #Chemicals #Regulation #EU

Register here: to join us on Tuesday, August 27, at 12pm ET, for a free and informative webinar where AgencyIQ’s research team will discuss the what the FDA still has on its plate in 2024. #AgencyIQ #Politico #FDA #Webinar

Last month, the FDA published a new draft guidance document on diversity action plans. AgencyIQ answers some of the most common questions we’ve received about the guidance – and raise a few of our own. Read here: #AgencyIQ #Politico #LifeSciences #FDA

In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the months ahead. Read more: #AgencyIQ #Politico #Regulation #EuropeanMedicine #MedicalDevice

Get the details on digital health updates, including: the Department of Health and Human Services’ new AI Office, FDA’s report on AI in surveillance, and coming policy. Read here: #AgencyIQ #Politico #LifeSciences #Regulation #FDA #HHS #NIST #AI

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead. Read here: #AgencyIQ #Politico #Chemicals #Regulation #Regulatory #EU

In this monthly resource, AgencyIQ looks at public data to determine what the FDA is likely to do in August and September. Read here: #AgencyIQ #Politico #LifeSciences #Regulation #Regulatory #FDA

The recently available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Read more: #AgencyIQ #Politico #IVDR

FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. Read more: #AgencyIQ #Politico #FDA #OMUFA #OTC