16 Jan 2019
There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.
1142 Total results for product and free and sample content found
By Michael Cipriano 16 Jan 2019
FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.
By David Filmore 16 Jan 2019
US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.
By Jung Won Shin 16 Jan 2019
2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.
By Jessica Merrill 16 Jan 2019
Annual payment plans for gene therapies appear closer to becoming reality now that bluebird bio detailed plans at J.P. Morgan. Novartis, Sarepta and others are also talking to payers about alternative payment models. Harvard Pilgrim's Michael Sherman applauded the effort in an interview.
By Alex Chiang + Adrian Watson 15 Jan 2019
What are the top 10 most common drug forecasting errors, and how can these be avoided? Life sciences consulting firm, Trinity Partners, explores the ins and outs of forecasting.
By Louisa Joseph 10 Jan 2019
The three urological cancers are undergoing tremendous changes in treatment practices as a result of new product launches and indication expansions.
By William Looney 10 Jan 2019
The clinical trial embodies the hope and the hassle of biopharma’s mission to develop new drugs for patients. It is an endlessly imperfect process: C-suite calls for more efficiency and speed at lower cost has been the story for decades. But an In Vivo conversation with a leading expert on trial management pinpoints three key trends that suggest better days are ahead for this central pillar of the innovation imperative.
Topic Clinical trials
By Amanda Maxwell 10 Jan 2019
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
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