Manufacturing

Manufacturing

Boston Scientific Cyberattack Halts Device Shipments

Aug 26, 20265 min read

Guidance

FDA Issues 55 New Bioequivalence Guidances for Generics

Aug 25, 20265 min read

Guidance

FDA Finalizes Guidance on Generic Drug TE Codes

Aug 23, 20266 min read

Guidance

FDA Revises Guidance on ANDA vs. 505(b)(2) Filings

Aug 20, 20265 min read

Manufacturing

FDA’s GDUFA IV Plan Would Raise Foreign Drug Fees

Aug 18, 20265 min read

Manufacturing

FDA Flags Novo Nordisk’s Indiana Plant as Highest Risk

Aug 17, 20266 min read

Manufacturing

FDA Grants Hearing on Generic Concerta After Decade

Aug 16, 20265 min read

Guidance

FDA Drafts New Guidance on Drug Container Closures

Aug 15, 20265 min read

Devices

TGA Suspends Supply of Corpuls Defibrillators

Aug 14, 20265 min read

Manufacturing

FDA Posts First Two Warning Letters Under New QMSR

Aug 13, 20266 min read

Devices

MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

Aug 6, 20264 min read

Devices

MHRA Flags Ventilator Failure Risk in Dräger Atlan Units

Aug 4, 20265 min read

Manufacturing

FDA Launches Council to Overhaul Its Inspections

Aug 3, 20266 min read

Devices

FDA Classifies Ventilator, Heart-Pump Recalls as Class I

Aug 3, 20265 min read

Guidance

FDA Drafts Rules for Biosimilar Autoinjectors, Syringes

Aug 3, 20265 min read

FDA

FDA Licenses the First Freeze-Dried Plasma for the US

Aug 2, 20265 min read

Guidance

FDA Finalizes Adhesion Rules for Generic Skin Patches

Aug 2, 20265 min read

Manufacturing

FDA Publishes Its Playbook for Fast-Track CMC Readiness

Jul 26, 20265 min read

Manufacturing

MHRA Approves the World’s First Low-Carbon Asthma Inhaler

Jul 24, 20265 min read

FDA

FDA Would Let Distributed Manufacturers Register Once

Jul 16, 20266 min read