Quality Systems

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

The pledge signifies ArisGlobal’s commitment to upholding high standards and best practices for the responsible use of artificial intelligence.

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers?

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

AI regulations in healthcare are rapidly evolving, and one should consult with regulatory subject matter experts, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

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

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

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

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.

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

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.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

Pharmaceutical Technology® spoke with Sujay Jadhav, CEO of Verana Health about trends in real-world data and the impact these trends will continue to have on the pharmaceutical industry in 2025.

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

The company is voluntarily recalling all lots of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30 mg/30 mL (1 mg/mL) 30 mL vials due to misleading labeling and its status as an unapproved drug.

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.