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.
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.
- The Optimizer Smart System, created by Impulse Dynamics, monitors heart activity and delivers non-excitatory electrical signals to the right heart valve.
India’s largest drug maker Sun Pharma on Monday said that it has received letter 483 (an observation of deviation in manufacturing practice) from the US Food and Drug Administration for its manufacturing plant in Baska Gujarat. Read more
Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 U.S. lawsuits alleging that their blockbuster blood thinner Xarelto caused unstoppable and in some cases fatal bleeding for a total of $775 million (588 million pounds), court documents on Monday showed
Companies that do not have much knowledge about how the FDA conducts inspections or are not ready for an audit always have difficulty. FDA inspections, announced ahead of time or not provide great opportunities to carefully examine the GMP compliance of pharmaceutical, biotechnology and medical device companies.
One part of an internal auditor’s life is the eventual (in some cases constant) contact with an auditee who plays some type of game. The reasons for auditee games are varied, but mostly they occur because the auditee believes (or knows) that the audit will not go well. Despite what we say, and do, most auditees equate a nonconformance with failure of them, or their department. Senior management often exacerbates the problem by placing internal audit performance in manager’s overall performance evaluation.
Almost entire Asia and Africa and major part of Latin America are out of the up to date PIC/S Guidelines and Aide Memoirs?
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