• Regulatory NewsRegulatory News

    MDCG offers clarity on ‘hybrid’ audits under MDR, IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified bodies flexibility in terms of how long an auditor is physically present on the auditee’s premises for audits conducted by notified bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).   MDCG has encouraged notified bodies to conduct hybrid audits to streamline conformity assessments, re...
  • Regulatory NewsRegulatory News

    FDA Class I device recall events ticked up in FY 2022

    While the total number of the most serious medical device recalls in the US has declined in recent years, the number of recall events has steadily increased, according to data from the Food and Drug Administration (FDA).   Focus analyzed FDA data from FY 2018-2022 and found that during the most recent fiscal year, the agency recorded 72 medical device Class I recall events comprised of 149 product recalls. The number of recall events reflects how many recalls occurred,...
  • ReconRecon

    Recon: Neuralink faces federal probe over animal tests; Emergent nabs priority review for OTC opioid overdose drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US delays backing for patent waivers on Covid-19 therapies and diagnostics ( STAT ) ( Reuters ) ( Bloomberg ) Musk’s Neuralink faces federal probe, employee backlash over animal tests ( Reuters ) ( Bloomberg ) FDA grants priority review for Emergent’s OTC opioid drug ( Reuters ) ( Biospace ) ( STAT ) US FDA Oncology, Device Centers Developing Public Diagnostic...
  • Regulatory NewsRegulatory News

    FDA warns Glenmark over GMP, laboratory control issues

    The US Food and Drug Administration (FDA) warned Indian generic drugmaker Glenmark Pharmaceuticals Limited for several good manufacturing practice (GMP) violations observed during an inspection of its Goa, India facility last May.   The warning letter, dated 22 November 2022, cites four violations related to investigating failed batches of drugs, written procedures for production and process control, laboratory controls and incomplete records.   Due to these issues...
  • RoundupsRoundups

    Asia-Pacific Roundup: New Zealand’s Medsafe retains classification of low-dose CBD

    The Medicines and Medical Devices Safety Authority (Medsafe) has recommended New Zealand keep its current regulatory classification of low dose cannabidiol (CBD), setting the country up to diverge from the position of its neighbor Australia.   At its latest meeting, Medsafe’s Medicines Classification Committee looked at the regulatory status of CBD, following the down-scheduling of CBD doses below 150 mg to pharmacy-only status by Australia’s Therapeutic Goods Administ...
  • Regulatory NewsRegulatory News

    ICH adopts Q13 guideline on continuous manufacturing

    The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing. In the final version of guidance, ICH acceded to industry’s request to clarify state of control and process dynamics.   ICH in late November had announced the adoption of the Q13 guidance but the document was not yet released. (RELATED: ICH touts adoption of continuous manufacturing, safety reporting g...
  • Regulatory NewsRegulatory News

    EMA calls to withdraw cough suppressant over allergic reaction risk

    The European Medicines Agency (EMA) has recommended that pholcodine-containing drugs be pulled from the European market after its experts agreed there was a significant risk of allergic reaction to neuromuscular blocking agents (NMBA). The recommendation has been sent to the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) for a final decision.   On 2 December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) announced ...
  • Regulatory NewsRegulatory News

    Uptake of biosimilars on the rise in the US, but number of marketed products lags other countries

    Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products that came on the market earlier.   These findings, published in JAMA Network Open , come from a cohort study evaluating market share and prices of biosimilars in the US, compared with Germany and Switzerland, which both hav...
  • ReconRecon

    Recon: Pfizer seeks authorization for bivalent booster in kids under 5; FDA takes firmer stance on dangling accelerated approvals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer applies for FDA authorization for Omicron-retooled vaccine booster in kids under 5 ( Reuters ) FDA Takes Tougher Line on Fast-Tracked Drugs ( WSJ ) Do Verve’s gene edits pass down to patients’ children? The FDA wants to know ( Fierce ) FDA remains silent on orphan drug exclusivity after last year's court loss ( Endpoints ) US FDA’s Non-Cancer Accelerat...
  • Regulatory NewsRegulatory News

    FDA updates statistical approaches for assessing bioequivalence

    The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications.   The update replaces a previous version in February 2001 and adds new topics such as assessing the bioequivalence for narrow therapeutic index (NTI) drugs and hig...
  • Regulatory NewsRegulatory News

    FDA revises ANDA facility correspondence draft guidance

    The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendment (GDUFA III) program.   The process can be used by generic drug sponsors to get a priority review goal date f...
  • This Week at FDAThis Week at FDA

    This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more

    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, we saw FDA approve the first fecal microbiota product, halt the emergency authorization of a COVID-19 antibody and advance guidance on the development of treatments for mpox.   This week, FDA approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota, live-jslm) to prev...