June 12th 2025
The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.
Industry Outlook 2025: Interesting Relations and Detailed Discussions on Data
February 27th 2025Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes in an interview with Pharmaceutical Technology®.
FDA Approves First Treatment for Rare Lipid Storage Disease Cerebrotendinous Xanthomatosis
February 24th 2025Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.
Ask the Expert: Complying with 21 CFR 211.110
February 20th 2025In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.
FDA Grants Full Approval for Symptomatic Tenosynovial Giant Cell Tumor Treatment
February 18th 2025Tenosynovial 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.
Drug Digest: Advances in Small-Molecule Manufacturing
February 14th 2025In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief commentaries on associated topics.
Sustainability in Inhalation and Small-Molecule Drugs
January 30th 2025Pharmaceutical Technology® spoke with Andy Burns, vice president, MDI Business Development at Kindeva, about how sustainability requirements are impacting contract development and manufacturing organizations, specifically for the development and manufacture of inhalation drugs.
Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging
January 23rd 2025Dirk 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.