• Regulatory NewsRegulatory News

    Manufacturers that are not testing DSCSA data systems now are in 'big trouble'

    While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these systems go live next November, said experts who recently spoke to Regulatory Focus.   Trading partners, for example, need to start testing and piloting data exchanges now to iron out any glitches early on, and manufacturers in particular ...
  • ReconRecon

    Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Analysis: Democrats score big wins on climate, drugs with $430 billion U.S. Senate bill ( Reuters ) ( Endpoints ) ( Pink Sheet ) ( STAT ) White House worked behind the scenes to push Senate toward breakthrough win ( The Hill ) Democrats dramatically narrow their ambitions for lowering insulin costs ( STAT ) Enhertu Goes Into High Gear With HER2-Low Breast Canc...
  • Regulatory NewsRegulatory News
    This Week at FDAThis Week at FDA

    This Week at FDA: EtO, user fee woes, and product specific guidances

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week the Environmental Protection Agency (EPA) said it would publish a new rule by year’s end that could have serious consequences for the ethylene oxide (EtO) sterilizers and the medtech industry; the head of the US Food and Drug Administration (FDA) tried to assure staff he’s doing...
  • Regulatory NewsRegulatory News

    FDA announces website for complex generics

    The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.   “Since these products are generally harder to develop, fewer exist, resulting in less market competition. This means that complex generics may be more expensive and less accessible to the patients who need them,” said the FDA announcement. “Complex generics are a key component of FDA’s Drug Competit...
  • Regulatory NewsRegulatory News

    Studies highlight role of US patent system in limiting competition

    Reforming the patent system for brand-name drugs in the United States could be more effective than changes to nonpatent exclusivities in encouraging generic competition, according to an analysis of patent protections for non-biologic prescription drugs.   “Our findings suggest that in the current market, patent lengths, rather than these other statutory exclusivities, are much more likely to be central considerations in drug manufacturers’ revenue predictions,” Victor ...
  • RoundupsRoundups

    Euro Roundup: Industry wants clarity on links between EHDS, existing legislation

    MedTech Europe is calling for clarity on aspects of the European Health Data Space (EHDS), including the interplay between the proposal and existing laws such as the new device and diagnostic regulations and the planned Artificial Intelligence Act.   The European Commission proposed creating the EHDS in May to facilitate better use of health data, including by making it easier and less costly for researchers to gain consent to use patient data. The draft plan grew out ...
  • ReconRecon

    Recon: FDA approves first interchangeable biosimilar for Lucentis eye drug; Amgen to acquire ChemoCentryx for $4 billion

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US   Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis ( Pink Sheet ) ( Endpoints ) Clinical Trials, Data Security Among US Federal Enforcement Priorities ( The Pink Sheet ) Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022 ( Endpoints ) Coming Soon: New US FDA O...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    FDA commissioner Robert Califf to speak at RAPS Convergence 2022

    The Regulatory Affairs Professionals Society (RAPS) is pleased to announce that US Food and Drug Administration (FDA) Commissioner Robert Califf, MD will speak at RAPS Convergence 2022, 11-13 September, in Phoenix, AZ at the Phoenix Convention Center.   After holding two years of virtual conferences, Convergence will commence its return to an in-person meeting with an opening plenary session where Califf will present on 11 September at 4:30 pm MDT. The commissioner w...
  • Regulatory NewsRegulatory News

    EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end

    The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a long-awaited rule later this year that could have serious consequences for medical device manufacturers as half of all US devices are sterilized with the gas.    On 3 August, the EPA announced it will finally publish a rule that stake...
  • Regulatory NewsRegulatory News

    EMA reports slow uptick in clinical trial applications submitted via CTIS portal

    The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.   Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to a...
  • Regulatory NewsRegulatory News

    EMA, HMA outline evolution of DARWIN EU real-world database

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-making.   Their joint Big Data Steering Group’s third workplan lays out a timeline to develop the Data Analysis and Real World Interrogation Network (DARWIN EU). According to the plan, by the end of this year, the research database will in...
  • Regulatory NewsRegulatory News

    Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies

    The US Food and Drug Administration (FDA) has issued draft guidance providing instructions for how generic drug manufacturers can electronically submit expedited individual case safety reports (ICSRs) for serious adverse events through the FDA Adverse Event Reporting System (FAERS). The draft guidance , issued on 02 August, applies to investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies. Expedited safety reports for IND-exempt BA/BE st...