• 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...
  • 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    The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs),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 official pushes for cloud-based regulatory assessments

    A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions.   Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at ...
  • ReconRecon

    Recon: FDA approves first FMT drug; Pfizer plans $1.26B Dublin expansion

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first fecal microbiome drug, setting stage for others ( STAT ) ( Endpoints ) ( MedPage Today ) ( Fierce ) FDA pulls U.S. authorization for Eli Lilly’s COVID drug bebtelovimab ( Reuters ) ( Endpoints ) Eisai, Biogen Alzheimers drug could be available to some next year ( Reuters ) Alzheimer’s drug shows promise but needs more study for safety, resea...
  • Regulatory NewsRegulatory News

    FDA warns Illinois eye clinic for conducting study without IND

    The US Food and Drug Administration (FDA) recently warned a clinical trial sponsor for failing to submit an investigational new drug application (IND) for its drug-device combination eye treatment and failing to obtain approval from an Institutional Review Board (IRB) before initiating clinical studies.   In a warning letter posted on 29 November, FDA told clinical investigator David Lubeck, of Arbor Center for EyeCare in Orland Park, IL that it found “objectionable co...
  • ReconRecon

    Recon: Second patient death linked to Alzheimer’s drug lecanemab rocks Eisai, Biogen; Roche withdraws Tecentriq’s bladder cancer indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche withdraws Tecentriq from U.S. bladder cancer indication ( Reuters ) ( Biospace ) ( Endpoints ) FDA rejects Crinetics' current PhII design for hyperinsulinism drug ( Endpoints ) Piloting Real-World Evidence: US FDA RWE Demonstration Projects ( Pink Sheet ) PhRMA, once invincible in Washington, has lost its edge ( STAT ) Resistance to FDA’s opioid-disposa...
  • 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...
  • 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

    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...
  • 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 ...
  • 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...