Regulatory Focus

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Regulatory Focus

 •  September 21

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the...

Regulatory Focus

 •  September 21

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical...

Regulatory Focus

 •  September 20

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.The guidance, intended not just for manufacturers of all device classes and drug-device...

Regulatory Focus

 •  September 19

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations. For Wuxi City-based Wuxi Medical Instrument Factory, FDA last March uncovered four violations, including one that involved the firm lying to FDA about...

Regulatory Focus

 •  September 18

As the US Food and Drug Administration (FDA) prepares to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), agency officials laid out some key considerations for sponsors looking to incorporate quantitative benefit-risk models in...

Regulatory Focus

 •  September 14

FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National...

Regulatory Focus

 •  September 14

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb). FDA’s approval of Mvasi follows an advisory committee’s unanimous backing of the treatment and is based on review of evidence that...

Regulatory Focus

 •  September 13

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday. Leah Christl, associate director for therapeutic biologics at the US Food and Drug Administration (FDA), on Monday...

Regulatory Focus

 •  September 13

An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act. In August 2016, FDA released the twodraft guidances, five years after...

Regulatory Focus

 •  September 12

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies (Focus, Video) What Does It Cost to Create a Cancer Drug? Less Than You'd Think (NYTimes) (NPR) (Medpage) Vertex shuts down study of long-acting Kalydeco but insists...