• Regulatory NewsRegulatory News

    Health Canada Consults on New Proposed Device Regulations

    Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices.   Specifically, the agency is proposing regulations that would amend the 2014 Protecting Canadians From Unsafe Drugs Act , commonly known as Vanessa’s Law, to extend some of its provisions to medical devices.   Under the proposal, device makers wo...
  • Regulatory NewsRegulatory News

    Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

    Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain. Ursula Roesler, head of medical devices at QS Zürich AG, told Focus that the medical device department will be closed by the end of October. As far as why the decision was made, Roesler said, “It was a business decision of the CEO—the investment was too high for a small NB like QS Zürich AG....
  • ReconRecon

    Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US There’s a fight brewing in Congress over pharma’s patents ( STAT ) With eyes on Gilead, lawmakers want details on how HHS reviews possible patent infringement ( STAT ) ( House Oversight ) No provisions in USMCA to change U.S. pharmaceutical patent laws: Lighthizer ( Reuters ) ( AAM ) Why Democrats reopened the debate about germline gene editing ( STAT ) Merck...
  • Regulatory NewsRegulatory News

    New Study Questions the Need for 12 Years of Market Exclusivity for Biologics

    The lengthy preclinical and clinical development necessary to bring a biologic to market has often been cited as one of the central reasons why biologics deserve 12 years of market exclusivity, or about five years more exclusivity than their small molecule counterparts. But a new study published Tuesday in Nature Biotechnology shows that the development time of a new biologic is generally about the same as the development time of a small molecule drug. The authors ...
  • Regulatory NewsRegulatory News

    FDA Releases New Data to Help Generic Drug Competitors

    Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday. Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that ...
  • Regulatory NewsRegulatory News

    EC Cautions on MDR/IVDR Impact on Device Availability

    In a factsheet posted Monday, the European Commission (EC) acknowledged that the EU’s medical device and in vitro diagnostic regulations (IVDR) “could have consequences for the availability of medical devices for health institutions,” with the potential for some devices to "become temporarily unavailable." The 7-page factsheet highlights the anticipated potential consequences from changes to the risk classifications of devices and IVDs, as well as the wider scope of b...
  • Regulatory NewsRegulatory News

    Study: Just Half of Postmarketing Commitment Trials are Published

    A new study published Monday in BMC Medicine finds that only about half of the clinical trials requested by the US Food and Drug Administration (FDA) as part of postmarketing commitments for newly approved drugs and biologics are published in peer-reviewed journals.   The study also found that information for nearly half of the postmarketing commitment studies subject to reporting requirements under section 506B of Federal Food, Drug, and Cosmetic Act (FDCA) was no...
  • Regulatory NewsRegulatory News

    EMA Begins Review of Handling Errors Linked to Leuprorelin

    At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts. EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the...
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    CDRH Discusses Evolution of Q-Submission Program

    Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) offered clarifications related to the Q-submission program’s evolution during a recent webinar. The Q-submission program is intended to provide a mechanism for sponsors of medical device submissions to request early interactions with agency staff prior to reaching the submission phase. A common question to CDRH relates to the newly introduced two-tiered review time...
  • ReconRecon

    Recon: Pfizer to Acquire Array Biopharma for $11.4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to boost cancer treatment portfolio with $11.4B Array deal ( Financial Times ) ( STAT ) ( Endpoints ) ( CNBC ) ( Press ) Pfizer CEO gets 61% pay raise—to $27.9 million—as drug prices continue to climb ( Ars Technica ) Gene therapy R&D deals turn red hot as Big Pharma steps up to play ( Endpoints ) Drug Prices Are a Populist Campaign Issue. Here Are the ...
  • Regulatory NewsRegulatory News

    EMA to Reinstate Some Activities Halted by Brexit

    While noting some progress in its Brexit preparations on transferring medicine marketing authorizations from the UK to the EU, the European Medicines Agency (EMA) on Monday announced a series of activities that will ramp up, in addition to the highest priority activities, for the remainder of 2019. But EMA also reiterated that between 20% and 25% of the agency’s staffers are expected to leave. And in the most recent EMA update, of the agency’s 776 staff members, 464 hav...
  • Feature ArticlesFeature Articles

    Regulatory Challenges in Medical Foods: Natural Variations in Ingredients of Agricultural Origin

    This article examines the sources of variability in raw materials from “natural origins” and how Foods for Medical Purposes (FSMP) companies cope with and overcome the challenges posed by regulated nutrient levels. The authors examine the sources of this variability using the examples of one vitamin (B12) and one trace mineral (selenium) and consider how FSMP companies work with the challenge of narrow acceptance criteria set by the regulations. The authors propose that re...