Regulatory Affairs

FDA Expands Early Alert Program for High-Risk Medical Device Recalls

On September 29, 2025, the FDA announced the expansion of its Early Alert program. This initiative is designed to improve…

Medical Device Field Safety Notices: Updates from August 25–29, 2025

Field Safety Notices issued between August 25 and 29, 2025, provide crucial updates for stakeholders involved in medical device oversight.…

IMDRF’s Safety and Performance Workshop: Key Insights for Regulatory Professionals

The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September 19, 2024, concentrating on…

Critical FDA Advisory: Updated Performance Alerts for BD Alaris Infusion Sets

An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under particular use conditions. Clinical,…

FDA Expands Access to Treatment Addressing Neurological Challenges in Autism

Meta description: The FDA has initiated approval for leucovorin calcium tablets to assist patients with cerebral folate deficiency, addressing autism-associated…

Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks associated with Profemur cobalt…

IMDRF Digitalizes Membership Applications: New Online Platform Launches

Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum (IMDRF) is transitioning its…

Understanding Medical Device Recalls: What Healthcare Professionals Need to Know

Medical device recalls are critical actions taken to address potential safety or regulatory violations associated with a device. Recently, updates…

FDA Reviews Risks: Acetaminophen in Pregnancy Linked to Autism Concerns

The FDA has announced a significant step in addressing emerging evidence regarding the use of acetaminophen (commonly known as Tylenol…

Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic

Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays a pivotal role in…

Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate

On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare products Regulatory Agency (MHRA)…

Critical FDA Update: BD Expands Class I Recall for Alaris™ Pump Infusion Sets

Meta Description: BD has expanded its voluntary Class I recall for Alaris™ Pump infusion sets, adding 15 discontinued models with…