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Manufacturing & Quality

Inspections, warning letters, OAI classifications, GMP and QMSR enforcement, CMC, compounding, packaging and supply disruption.

26 stories

Regulatory News has published 26 Manufacturing & Quality stories between 16 July 2026 and 20 October 2026, each sourced to the primary record — the Federal Register entry, the Official Journal notice, the guidance document or the regulator’s own release — and written and edited by Connor Griggs, the publication’s editor. Last updated 20 October 2026.

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26 stories, newest first.

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Showing 26 of 26 stories

A pharmaceutical executive in a bright office, standing in for UCB's autoinjector approval announcement Drugs & Biologics FDA Approves Autoinjector for UCB's Zilbrysq Oct 20, 20266 min read Read the story The United States Capitol dome in Washington, D.C., framed by trees under a blue sky Manufacturing & Quality Par Health Recalls Argatroban Over Particulate Matter Oct 17, 20265 min read Read the story Exterior of a modern glass-and-concrete corporate campus building under a clear blue sky Manufacturing & Quality Olympus Discloses New FDA Warning Letter Over QMS Oct 16, 20266 min read Read the story A regulatory team briefing stands around a whiteboard in a bright office Guidance & Policy FDA Finalizes Biosimilar Manufacturing-Change Rules Oct 10, 20266 min read Read the story A pharmacist and a customer examine a medication package in a pharmacy Manufacturing & Quality Par Health Recalls Brevital Sodium Over Cellulose Oct 10, 20265 min read Read the story Three colleagues with lanyards review printed documents around a table Manufacturing & Quality FDA Warns Amazon, Walmart Over Herpes Cream Claims Oct 8, 20267 min read Read the story A doctor and nurse confer in a hospital corridor Manufacturing & Quality FDA Recall: Compounded Glutathione Tied to ED Visits Oct 8, 20266 min read Read the story A scientist in a lab coat and safety glasses examines a sample through a microscope while holding a pipette Manufacturing & Quality FDA Hits Fresenius Kabi With Second Warning Letter Oct 6, 20267 min read Read the story Two colleagues review and sign paperwork together at an office table Drugs & Biologics Alvotech Wins FDA Nod to Double Simlandi Production Oct 5, 20265 min read Read the story A gloved clinician in scrubs reviews a printed document by a bright glass-block window Manufacturing & Quality FDA Cites Sterility Risk in Spectra Saline Flush Recall Sep 28, 20266 min read Read the story A woman holds an open red folder and reviews its contents while a colleague looks over papers behind her in a brick-walled office Manufacturing & Quality Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain Sep 27, 20264 min read Read the story A man in a dark suit reads intently from an open yellow folder at a wooden desk Devices & Diagnostics France Pulls Getinge Vascular Grafts Over Yarn Defect Sep 27, 20264 min read Read the story Two researchers in white and blue lab coats examine chemical flasks on a laboratory bench Manufacturing & Quality FDA Hits Empower Pharmacy With Fifth Warning Letter Sep 24, 20266 min read Read the story A scientist in a white lab coat and blue nitrile gloves stands at a laboratory bench beside petri dishes and glass flasks Manufacturing & Quality Teva Canada Recalls Acetaminophen Over Resin Risk Sep 13, 20264 min read Read the story A close-up of a hand signing an official multi-page form on a desk, with reading glasses resting nearby Guidance & Policy EMA Extends PV Inspections to Cover Subcontractors Sep 12, 20264 min read Read the story A scientist in a lab coat carefully pours liquid from a flask into a beaker for measurement Guidance & Policy FDA Eases Compounding Rules for Newborn IV Nutrition Sep 11, 20265 min read Read the story Two officials in business suits at a conference table with a U.S. flag, one signing a document Manufacturing & Quality Boston Scientific Cyberattack Halts Device Shipments Aug 26, 20265 min read Read the story The US Capitol building with its dome and colonnade under a bright blue sky Guidance & Policy FDA's GDUFA IV Plan Would Raise Foreign Drug Fees Aug 18, 20265 min read Read the story Two gowned technicians in hairnets and masks conferring over a microscope and lab notes in a cleanroom Manufacturing & Quality FDA Flags Novo Nordisk's Indiana Plant as Highest Risk Aug 17, 20266 min read Read the story A government building dome with classical columns rises above a city skyline at sunset Guidance & Policy FDA Drafts New Guidance on Drug Container Closures Aug 15, 20265 min read Read the story Two masked lab researchers in white coats and safety glasses review notes on a clipboard beside a microscope Manufacturing & Quality FDA Posts First Two Warning Letters Under New QMSR Aug 13, 20266 min read Read the story A low sun lights the dome and pediment of a neoclassical government capitol building against a deep blue sky Devices & Diagnostics MHRA Lifts Suspension on Belzer Organ-Preservation Fluid Aug 6, 20264 min read Read the story The dome of the U.S. Capitol rises against a partly cloudy blue sky, framed by trees on the west lawn Manufacturing & Quality FDA Launches Council to Overhaul Its Inspections Aug 3, 20266 min read Read the story Blister packs holding rows of blue, yellow, white, and pink tablets, viewed close up on a wooden table Manufacturing & Quality FDA Publishes Its Playbook for Fast-Track CMC Readiness Jul 26, 20265 min read Read the story A woman in a lilac blazer speaks into a microphone while reading from a paper at a wooden lectern Drugs & Biologics MHRA Approves the World's First Low-Carbon Asthma Inhaler Jul 24, 20265 min read Read the story A scientist working at a cabinet in an FDA laboratory Manufacturing & Quality FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story