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Baxter Warning Letter highlights systemic...

A September 2026 FDA Warning Letter to...

MHRA outlines AI and MedTech...

The UK Medicines and Healthcare products Regulatory...

Baxter Warning Letter highlights systemic weaknesses in contamination control

A September 2026 FDA Warning Letter to Baxter International identifies deficiencies in cross-contamination prevention, aseptic processing, environmental monitoring and quality investigations. The findings highlight why a documented Contamination Control Strategy (CCS) must be supported by evidence that manufacturing processes remain under control. The US Food and Drug Administration (FDA) issued a Warning Letter to Baxter International on 29 September 2026 following an inspection of Baxter Healthcare Corporation’s manufacturing facility in Round Lake, Illinois, from 23 March to 2 April 2026. The FDA identified significant violations of current good manufacturing practice...
TOP-Pharma Editorial Team -
Findings & Enforcement

Baxter Warning Letter...

A September 2026 FDA Warning Letter to Baxter International identifies deficiencies in cross-contamination prevention, aseptic processing, environmental monitoring and quality investigations. The findings highlight...
TOP-Pharma Editorial Team -
Medical Devices

MHRA outlines AI...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) outlined its evolving approach to artificial intelligence (AI) and medical device regulation at AdvaMed 2026,...
TOP-Pharma Editorial Team -
Documents

AI in drug...

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly developed Guiding principles of good AI practice in drug...
TOP-Pharma Editorial Team -
Manufacturing

FDA, Sanofi and...

At the 2026 PDA/FDA Joint Regulatory Conference, representatives from the US Food and Drug Administration (FDA), Sanofi and Gilead Sciences discussed how pharmaceutical manufacturers...
TOP-Pharma Editorial Team -
Regulatory Affairs

AI in drug...

2024 sees a pivotal moment in AI-driven drug development with diverse global stances. This piece delves into the potentials, key details, and unique features of AI in pharmaceuticals.
TOP-Pharma Editorial Team -
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