Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.
Two medical device manufacturers have been granted the first certificates under the EU’s new regulations that are coming into force next year. Medtech looks at whether this is a sign that the whole sector is going to be able to meet regulations.
Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.
Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.
“Junk science” is being blamed for a lawsuit filed against Unilever for alleged “micro-tears” caused by their St. Ives Apricot Scrub. The suit, first filed in 2016, may be coming to the end of the road, as Unilever requests a summary judgement in the matter.
The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.
A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.
As Democrats gained a majority in the House after the 2018 US midterm elections, many wonder who will be on their radar when they turn their attention to holding hearings on drug pricing. The answer? It’s not likely to be the FDA.
Commissioner Scott Gottlieb announced that exclusivity for certain existing protein products will not be extended further, in remarks made at the FDA/CMS Summit. The announcement affects existing products, including insulin and human growth hormone, that, under the Public Health Service Act, are “deemed to be licensed” in 2020.
After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.
The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.
Find out the circumstances surrounding the unexpected positive results that the January 2019 US government shutdown (including the shutdown of US FDA) had on a breakthrough allergy immunotherapy in this thoughtful analysis from the industry experts at Pink Sheet.
At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.
Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.
The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.
Sign up to the Pharma Intelligence Report Store Newsletter to get the latest blogs, news, reports and discounts!