In an effort to support innovation in the development of gene therapy products, the FDA has released guidance to provide regulatory clarity for product developers.
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Watch Data Scientist Patrick O’Sullivan of Janssen describe how they reduce the amount of time spent preparing data for their million data point systems.
AstraZeneca’s new carbon emission plan includes a 100 percent electric vehicle fleet and a 50 million tree reforestation plan.
The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
The pharmaceutical industry saw some notable mergers and acquisitions in 2019; this article lists the top 10 by transaction size.
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
A partnership between Novartis and NHS England includes a proposal to investigate processes that can increase the scale and efficacy of oligonucleotide manufacture.
The pharmaceutical packaging equipment market is expected to reach a value of $11.46 billion due to market leader innovations and tightening packaging regulations, says report.
Price caps and government regulations will not lower US healthcare costs, instead supply chain and drug pricing reforms are required, says a brief by medical economist.
Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.