Topic

Articles

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Provepharm Recalls Phenylephrine Hydrochloride Injection

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Sustainability in Pharmaceutical Manufacturing

Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.

Dealing with Challenging APIs

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

EMA Prepared for Health Technology Assessment Regulation Implementation

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Cavazzoni Retires as CDER Director

Feliza Mirasol is the science editor for 

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

Quality Systems