• ReconRecon

    Recon: Biogen nabs priority review for ALS therapy, despite phase 3 miss; Pfizer, BioNTech file US suit against CureVac

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 ( Fierce ) ( Reuters ) ( Endpoints ) ( STAT ) Novartis generics arm files for MS biosimilar, challenging Biogen; Pluristem shortens name ( Endpoints ) Incurable Cancer Patients to See Eased Path to Clinical Trials ( Bloomberg ) Out-of-pocket cap will increase the net price ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Malaysia’s NPRA details pilot project for track and trace system

    Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated the industry on plans to run a pilot project for an end-to-end track and trace platform designed to improve on the existing hologram safety label system.   The Malaysian government is developing a system that covers the entire supply chain, from product registration holders, manufacturers and importers through to the end user and will begin a six-month pilot program in January.   According to N...
  • Regulatory NewsRegulatory News

    FOCR offers path for validating ctDNA as an early endpoint for drug approval

    Friends of Cancer Research (FOCR) has issued an evidentiary roadmap for validating circulatory tumor DNA (ctDNA) as an early endpoint for accelerated drug approval in solid tumors, spelling out a strategy for generating the data needed to support the use of ctDNA levels as a drug development tool in regulatory decision making.   The roadmap builds on earlier work on ctDNA from FOCR, including a white paper outlining opportunities to use ctDNA in early-stage cancer an...
  • Regulatory NewsRegulatory News

    FDA loosens UDI requirements for lowest risk devices, extends deadline for others

    The US Food and Drug Administration is relaxing its unique device identified (UDI) rule requirements for low-risk class I consumer health products. Other class I and unclassified devices will still need to follow UDI requirements, though FDA announced it will extend its compliance deadline for those devices to 8 December 2022.   On 22 July FDA released a final guidance titled, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassifie...
  • Regulatory NewsRegulatory News

    EMA consults on ICH M12 guideline for drug-drug interaction studies

    The International Council for Harmonisation (ICH) has released a draft guideline with recommendations on designing, conducting and interpreting drug-drug interaction (DDI) studies involving interactions mediated by enzymes and/or transporters that occur in vitro during the development of an investigational therapeutic drug.   ICH’s draft M12 guideline, which was adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use and released for...
  • ReconRecon

    Recon: Biden admin embarks on effort to develop next-gen COVID-19 vaccines; EU approves Bavarian Nordic’s Monkeypox vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House to launch effort to develop next generation of Covid vaccines ( STAT ) ( Barrons ) FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals ( Fierce ) Biden administration weighs declaring monkeypox a health emergency ( Washington Post ) ( Reuters ) Monkeypox ‘Can Be Contained” in US, White House Doctor Says ( Bloomberg ) S...
  • Regulatory NewsRegulatory News

    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Remote regulatory assessments guidance, 12-digit NDCs, 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, FDA released its long-awaited guidance on how it plans to incorporate remote regulatory assessments across product areas going forward. The agency also issued a proposed rule to adopt a uniform 12-digit format for national drug codes (NDCs) and updated its list of medical devic...
  • Regulatory NewsRegulatory News

    FDA warning letter tells Spanish API firm to up its validation game

    A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain in a state of control and can consistently produce a quality product.   The letter to Bioiberica SAU in Barcelona, Spain, which makes heparin-based products, in addition to APIs, follows an inspection between 31 January and 4 February ...
  • Regulatory NewsRegulatory News

    Concerns rise that Congress may miss budget, user fee renewal deadlines

    With just over two months to go, it’s increasingly looking like Congress is going to miss its deadlines to pass a final US Food and Drug Administration appropriations bill and a user fee reauthorization bill.   On 20 June, Democrats in the US House passed a $400 billion “minibus” appropriations bill in a 220-207 vote that largely split down party lines. That means it’s now up to the Senate to pass a similar bill, but lawmakers in the upper chamber haven’t even publicly...
  • ReconRecon

    Recon: Roche CEO to step down after 14 years; WHO to roll out first malaria vaccine in Africa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Officials reorganize HHS to boost pandemic response ( Washington Post ) ( Reuters ) ( Politico ) Worried by Supreme Court, U.S. House votes to protect contraception ( Reuters ) Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief ( STAT ) President Biden tests positive for Covid-19, but has ‘very mild symptoms’ ( STAT ) Biogen agrees to pay $90...
  • RoundupsRoundups

    Euro Roundup: MHRA misses performance targets amid resource constraints, Brexit backlogs

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed multiple performance targets for its 2021-2022 financial year due to resource constraints, Brexit backlogs, and additional reasons.   MHRA started the financial year aiming to produce 97% of validation reports for new marketing authorization applications within 14 days of case creation; instead, the agency achieved the 14-day target 83.4% of the time.   “Embedding centrally authorized products...