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1142 Total results for product and free and sample content found

Medtech Insight

NZ To Replace Outdated And Piecemeal Device Rules

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.

Topic Medtech

Pink Sheet

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

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.

Topic FDA

Medtech Insight

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

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.

Topic FDA

Scrip

Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed

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.

Topic FDA Business strategies

Scrip

The Gene Therapies Are Coming – And So Are New Ways To Pay For Them

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.

In Vivo

You May Be Making These Drug Forecasting Mistakes

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.

Topic Drug approval Drug review

Datamonitor Healthcare

Clinical Breakthroughs in Urological Cancers can be a Double-Edged Sword as Payers are Forced to Act

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.

Topic Cancer

In Vivo

Clinical Trials In 2019: Is Biopharma Ready To Tackle The Iron Triangle of Time, Cost and Quality?

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

Medtech Insight

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

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.

Topic Brexit

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