• Regulatory NewsRegulatory News

    FDA Cites Korean Manufacturer Over Unapproved Device

    In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations.   FDA’s review of the manufacturer’s website found its Y-PRP system falls under the FD&C Act’s definition of a medical device. For example, the website states the Y-PRP system “facilitates separating and harvesting ‘pure sources of concentrated platelets’ without much skill.”   But the ...
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    Recon: Sales of Essure birth control implant halted by Bayer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Sales of Essure birth control implant halted by Bayer; U.S. was last to sell controversial device ( The Washington Post ) ( NYT ) Novartis Sues to Block Generic Sales of Top Drug Gilenya for MS ( Bloomberg ) ( Fierce ) Merck Is Lowering Drug Prices. There’s a Catch. ( NYT ) ( WSJ ) ( The Hill ) ( Reuters ) Risks Just Rose for Drug Middlemen ( WSJ...
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    Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump Plan to Lower Drug Prices Moves Forward on Several Fronts ( Bloomberg ) ( STAT- $) ( WSJ -$) Trump thanks major pharma companies for not raising prices ( New York Post ) ( Reuters ) ( The Washington Post ) Roche takes Tecentriq hit on survival data ( Reuters ) ( Endpoints ) In two PhIII wins for Allergan/Molecular Partners, wet AMD drug shows ...
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    FDA Adopts ICH Addendum on Multiregional Clinical Trials

    The US Food and Drug Administration on Wednesday adopted an addendum to the International Council for Harmonization's (ICH) guidance aimed at supporting drug sponsors in the collection of data from multiregional clinical trials (MRCTs).  The guidelines in E17 General Principles for Planning and Design of Multi-Regional Clinical Trials detail seven “basic principles” to follow when designing MRCTs.  Identified principles include “prespecified pooling of regions or subp...
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    FDA Revises 1998 Guidance on 510(k)s for Biliary Stents

    The US Food and Drug Administration (FDA) is revisiting 1998 guidance on metal expandable biliary stents to provide up-to-date recommendations for 510(k) submissions.   The 27-page draft guidance has a substantial amount of new recommendations compared to what was included in the past guidance , which in nine page merely outlined the recommended format.   “This draft guidance applies to metal expandable biliary stents indicated for [relief from narrowing of the bi...
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    Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Bill Gates jump-starts research for an affordable Alzheimer's test ( CNN ) ( Fortune ) ( Forbes ) Novartis shelves US price increase ( Financial Times ) ( CNN ) ( WSJ ) ( Bloomberg ) ( Reuters ) Pfizer-Lilly pain drug meets late-stage trial goals ( Reuters ) ( BioPharma Dive ) ( Endpoints ) ( Fierce ) Sanofi bags rights to Revolution’s SHP2 cancer drug ( Fierce )...
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    Recon: Mylan Signs Licensing Deal on Humira with AbbVie

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US South Dakota judge blocks drug price cap measure from ballot ( AP News ) ( STAT ) Pharma fuels Johnson & Johnson's earnings beat, consumer lags ( CNBC ) ( Reuters ) ( WSJ ) Mylan signs U.S. license deal on Humira with AbbVie ( Reuters ) ( The Center for Biosimilars ) Roche hands over another batch of positive PhIII data on its new flu drug, looking ...
  • Regulatory NewsRegulatory News

    Health Canada Clarifies Policies for Notifications of Foreign Regulatory Actions

     Health Canada issued new guidance on Thursday to aid pharmaceutical companies in complying with previously set requirements on notifications of foreign regulatory actions.   The guidance operationalizes Health Canada’s interpretation of the notification requirements under provisions of the Protecting Canadians from Unsafe Drugs Act .   “These provisions are intended to improve the collection and assessment of new relevant safety information in respect to any seri...
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    Pfizer’s Hospira Site in India Lands Another FDA Form 483

    In a 32-page US Food and Drug Administration (FDA) Form 483, 11 citations revealed manufacturing and quality control issues at the Hospira Healthcare India facility in Tamil Nadu.   FDA visited the manufacturing facility over the course of six days from March through early April and found seven nonconformities relating to the firm’s laboratory system. These ranged from unreliable microbiology laboratory data and manipulated test sample weights to a lack of stability-in...
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    Recon: FDA Panel Backs Malaria Drug; Senate Report on Trump Lawyer and Novartis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Senate Democrats blast former Trump attorney for 'selling access' to White House ( ABC News ) ( Endpoints ) ( STAT ) ( Business Insider ) ( Bloomberg ) ( Report ) HHS OIG Report on Tom Price’s Flights ( Report ) ( NYT -$) Amgen, UCB are back pitching once-rejected osteoporosis drug to the FDA — but big hurdles lie ahead ( Endpoints ) ( Fierce ) FDA P...
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    Recon: Novartis joins exodus out of antibiotics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Novartis joins the Big Pharma exodus out of antibiotics, dumping research, cutting 140 and out-licensing programs ( Endpoints ) ( Bloomberg ) ( Fierce ) Nevada Execution Halted on Drugmaker’s Lawsuit ( WSJ ) ( NYT ) ( Reuters ) Top Dem demands more details on pricing deal between Pfizer and Trump ( The Hill ) ( STAT- $) Zogenix's seizure drug clea...
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    CDRH Draft Plan for Abbreviated 510(k) Option Raises Questions

    The Medical Imaging & Technology Alliance (MITA) and AdvaMed, among others, voiced concerns with how FDA’s Center for Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program as described in a draft guidance from April.   The draft left commenters puzzled since agency officials had indicated the expanded program would allow for greater flexibility when the plans were first announced last year. The industry groups commended ...