• Regulatory NewsRegulatory News

    FDA finalizes enforcement policy for FMT treatments

    In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota treatments (FMT) being developed in investigational new drug applications (INDs) for Clostridioides difficile infections (CDI) in patients who do not respond to standard therapies.   The final guidance reaffirms the draft version in affirming that regulatory discretion will not apply to FMTs obtained from stool ba...
  • Regulatory NewsRegulatory News

    FDA looks to modeling and simulation tools to streamline product reviews

    The US Food and Drug Administration (FDA) recently published a report on how it uses modeling and simulation (M&S), highlighting the untapped opportunities to improve efficiency and predictability at the agency. Some of the key opportunities identified in the report are the need to develop guidelines for using such tools in the premarket setting and to harmonize how they are used among its product centers, international regulators and industry.   Modeling and simulatio...
  • ReconRecon

    Recon: Spectrum cuts 75% of staff following FDA rejection; WHO to rename monkeypox as ‘mpox’

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Accepts BLA for Roche & Sarepta’s DMD Gene Therapy ( Biospace ) ( Pharma Letter ) ( Endpoints ) FDA won't hold adcomm for BioMarin's hemophilia gene therapy after all ( Endpoints ) FDA pushes back Gamida Cell’s PDUFA date by three months ( Endpoints ) FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial ( Endpoints ) Industr...
  • 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 ...