The FDA has approved Novartis-subsidiary AveXis Inc’s spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi). The company wants to set the price tag at $2,125m per dose.
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A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues. Cadila Healthcare Ltd., Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. […]
FDA investigators are knocking at your door—are you ready? Your first thoughts may be of logistics— meeting space, document availability, the condition of your facility—but what about personnel? Are your employees prepared to face FDA investigators who are trained to thoroughly investigate a manufacturer’s entire operation?
A new drug to treat spinal muscular atrophy (SMA) approved by the Food and Drug Administration (FDA) on Friday will come with a price tag of $2.1 million, making it the most expensive medicine in the world.
Asking the right question begins in the preparation phase of the GMP Audit. An understanding of the requirements, the SOPs, work instructions and forms play a major role in asking the right questions. Use this information to generate a checklist that is meaningful. Before the GMP Audit, you should know what you are going to […]
Be prepared A GMP Internal Audit’s success often hinges on preparation. Generally, an extensive GMP Internal Audit requires considerable preparation to identify opportunities for mutual gain. Before a GMP Internal Audit begins, you should make sure that you know the procedures better than the supervisor of the department being Audited.
The US health authority Food and Drug Administration (FDA) carries out domestic and foreign inspections to investigate whether an organization works in accordance with the US law (Code of Federal Regulations, CFR) and international guidelines. For the production and control of classically and biotechnologically manufactured pharmaceuticals, the American laws Current Good Manufacturing Practices in Manufacturing, […]
Unfortunately there is no perfect number of GMP Auditors a Pharmaceutical & Biotechnology company must have to perform effective GMP Internal Audits. Some companies, particularly those in the Aerospace, Nuclear and Automotive Industries, are fortunate enough to have full time Internal Auditors.
Artificial Intelligence (AI) ‘deep learning’ has been found to detect malignant lung nodules on low-dose chest computed tomography (LDCT) scans sooner than radiologists.
Amgen has agreed to buy Swedish biotech Nuevolution for around $167 million to boost its drug pipeline after an R&D collaboration showed promise.