• Regulatory NewsRegulatory News

    European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates Data Quality Control, IT Papers as Introduction of New Process Nears The European Medicines Agency (EMA) has updated documents on data quality control and electronic filings ahead of the introduction of a new process in November. EMA will start using the new process on 4 November, at which time the regulator will start sending out alerts every time it vali...
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    FDA Calls for 'Cautionary Approach' on Brazilian Manufacturer's Suspended Implants

    The US Food and Drug Administration (FDA) told RAPS' Regulatory Focus that it concurs with breast implant provider Sientra's caution in voluntarily placing a temporary hold on the US sales of all devices from Brazilian implant manufacturer Silimed. "We concur with Sientra’s recommendations to take a cautionary approach until more is known, and we are actively working with the company and other international regulators to investigate the issue. The FDA is in close c...
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    Fallout Continues from MHRA Suspension of Brazilian Manufacturer's Implants

    Two days since the UK's Medicines and Healthcare products Regulatory Agency (MHRA) halted all sales of Silimed's silicone implants, and at least two other regulators have followed suit, while Silimed insists its devices are safe and has criticized MHRA's criteria for particle levels. Background MHRA on Wednesday suspended the CE certificates of the Brazilian device manufacturer Silimed, which claims to be the largest manufacturer of silicone implants and the largest b...
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    MHRA Suspends All Devices from Largest South American Silicone Implant Manufacturer

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA), alongside EU member state regulators, announced Wednesday the suspension of all CE certificates for medical devices made by Brazilian manufacturer Silimed. The suspension comes as a German notified body recently inspected one of the Brazilian manufacturing sites of Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, and ...
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    Are Notified Bodies Responsible for the Failure of Companies They Oversee?

    A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports. Background For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut ...
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    European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular. SCENIHR's report concludes th...
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    FDA Finalizes Guidance Aimed at Accelerating Approval for Some Breast Cancer Treatments

    A new final guidance document issued by the US Food and Drug Administration (FDA) outlines the processes by which the regulator will accept surrogate endpoints to support the accelerated approval of treatments intended for high-risk early-stage breast cancer. Background Under normal circumstances, FDA requires "substantial evidence"—generally two Phase III clinical trials—indicating that a product is safe and effective at treating, preventing or curing a given condition...
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    Pfizer Launches Expanded Access Program for Breast Cancer Drug

    The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly differen...
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    UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage. Kadcyla (trastuzumab emtansine) treats women with m...
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    FDA: Companies Developing Breast Cancer Drugs Should Also Enroll Men

    Chances are good that if you hear the term "Breast Cancer," the image it will conjure up is of a female patient with breast cancer—a reasonable association given that the overwhelming majority of breast cancer cases (99%) affect women. And as regulators note this week, there's a strong association between females and breast cancer when it comes to new drug approvals, too. Companies studying drugs intended to treat breast cancer have "historically" enrolled only wo...
  • European Commission Report Calls for Restricted Use of Metal-on-Metal Hip Implants

    The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a scientific committee which conducts risk assessments for EU officials-has announced the publication of its initial draft assessment of the safety of metal-on-metal hip implants. Background Metal-on-metal hip implants have been plagued with controversy around the globe. The devices, which claimed to be similar enough to predicate devices made with non-metal parts, have...
  • Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison

    • 10 December 2013
    The former CEO of a now-disgraced manufacturer of breast implants that was accused of willfully misleading regulatory officials for years has been found guilty by a French court and sentenced to four years in Jail. Background Jean-Claude Mas, former CEO of the now-defunct manufacturer Poly Implant Prothese (PIP), was accused in 2010 of distributing hundreds of thousands of breast implant products made with deficient, industrial-grade silicone without the approval of reg...