Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT...

USA – FDA finalizes enforcement policy for FMT treatments

In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota...

USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...

The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...

USA – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...

Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in...

Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have...
FDA finalizes contentious guidance on third party 510(k) reviews

USA – FDA revises ANDA facility correspondence draft guidance

The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...

UK – NICE recommends Takeda’s Ninlaro triplet regimen

Therapy involves patients living with relapsed or refractory multiple myeloma Takeda has announced that the National Institute for Health and Care Excellence (NICE) has recommended...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – European Parliament committee proposes changes to pharma legislation

The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that...