• Regulatory NewsRegulatory News

    FDA’s top 10 tips to transition your COVID-19 products

    During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency use authorization (EUA) or enforcement discretion. Those products can’t stay on the market indefinitely – and a top agency official has some tips on how to transition such products to traditional marketing pathways.   Focus recently spoke with William Maisel, chief medical officer and director of the Office of Pro...
  • Regulatory NewsRegulatory News

    ICH touts adoption of continuous manufacturing, safety reporting guidelines

    The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM).   These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and...
  • Regulatory NewsRegulatory News

    FDA releases guidance on compounding beta-lactam products in shortage

    The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam oral antibiotic suspension products.   The agency said it has been asked to clarify how compounded versions of products from FDA-approved tablets and capsules currently in shortage can be prepared, as FDA’s insanitary conditions guidance states beta-lactam drugs are required to be processed with “complete ...
  • ReconRecon

    Recon: GSK will pull blood cancer drug from US market following study setback; Teva, AbbVie finalize $6.6B US opioid settlements

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule ( Fierce ) ( FDA ) Palisade Bio is Granted Fast Track Designation from the U.S. Food and Drug Administration for LB1148 for Accelerated Return of Bowel Function following GI Surgery ( Biospace ) Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes ( Scrip ) ( STAT ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Malaysia’s MDA updates guidance on labeling, change notifications for devices

    Malaysia’s Medical Device Authority (MDA) has updated its guidance on the requirement for labeling of medical devices and the handling of change notifications of authorized products.   MDA published the fifth edition of the labeling guidance in June, but has since identified a few things to change, resulting in a sixth edition released this week that hews closely to its predecessor. MDA has deleted two definitions “generic name” and “specific name” from the glossary an...
  • Regulatory NewsRegulatory News

    Industry asks FDA to align quantitative labeling guidance with other regulators

    Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators.   The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of so...
  • Regulatory NewsRegulatory News

    EMA offers insights on when biologics qualify as new active substances

    The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances are considered new active substances (NAS). The document walks sponsors through the factors to consider when determining whether a NAS claim meets regulatory requirements.   On 18 November, European regulators asked stakeholders for comments on its recently published reflection paper on NAS . Generally, for “w...
  • ReconRecon

    Recon: Merck pens $1.4B deal to acquire Imago to bolster bone marrow disease pipeline; Teva names former Sandoz head as next CEO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Apellis’ closely watched eye drug gets new FDA goal date after changes to its filing scared investors ( Fierce ) FDA hits Iovance with one more delay for TIL therapy, extending BLA filing until 2023 ( Endpoints ) FDA Action Alert: Spectrum, ImmunoGen, Scynexis and Y-mAbs ( Biospace ) Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regula...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Califf and Pazdur on return to office, accelerated approval, 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 heard from FDA Commissioner Robert Califf and Oncology Center of Excellence (OCE) Director Richard Pazdur about FDA’s return to office plans, accelerated approvals and a new initiative called Project Pragmatica.   FDA’s Cardiovascular and Renal Drugs Advisory Committee ...
  • Regulatory NewsRegulatory News

    FDA official discusses benefits, challenges of remote inspections

    The use of remote regulatory assessments (RRAs) has helped the US Food and Drug Administration (FDA) identify “significantly deficient” good manufacturing practice (GMP) violations when officials cannot visit sites. Yet the program does pose some technical and logistical challenges, which can interfere with a manufacturer’s ability to respond to requests for records.   So asserted Ashar Parikh, foreign pre-approval inspection manager for FDA, who spoke on some of the l...
  • Regulatory NewsRegulatory News

    FDA outlines plan for ‘agency-wide approach’ to cybersecurity

    The US Food and Drug Administration (FDA) has released a new action plan for approaching cybersecurity, outlining its mission to upgrade, enhance and modernize its defenses to assets and data at the agency.   “Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks,” Vid Desai, chief information officer and Craig Taylor, chie...
  • Regulatory NewsRegulatory News

    FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections

    A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools.   Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program divis...