• Regulatory NewsRegulatory News

    FDA publishes two critical DSCSA draft guidances

    The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.   The agency announced that “these documents are critical steps toward implement...
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    Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA to convene second panel of outside experts to review Amylyx Pharma’s ALS treatment ( STAT ) ( Endpoints ) ( Reuters ) Novavax expects COVID vaccine targeting Omicron in fourth quarter ( Reuters ) Can Biogen’s backup plan for Alzheimer’s succeed? ( Boston Globe ) Another Duchenne clinical hold gets lifted, this time at Dyne Therapeutics ( Endpoints ) FDA C...
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    FDA tells Dutch API producer to clean up its equipment act

    A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration (FDA) dated 14 June. FDA found the presence of “visible powder residue” on non-dedicated equipment.   The warning letter pertained to Fagron Group B.V.’s manufacturing site in Saint Paul, MN. The company is headquartered in ...
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    Recon: US signs $3.2B deal for Pfizer-BioNTech vaccines; Novartis said to lean toward spinoff of generics unit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters ( Reuters ) As booster season awaits, US re-ups supply of Pfizer Covid-19 vaccine with new $3.2B deal ( Endpoints ) ( Reuters ) ( Fierce ) ( Bloomberg ) Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid ( Reuters ) Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Ad...
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    ICMRA explores hybrid inspections, postapproval changes with new pilots

    A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.   The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufac...
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    Recon: Pfizer, BioNTech to test universal coronavirus vaccine; ARCH raises $3B fund for biotech startups

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant ( Endpoints ) ( STAT ) ( Reuters ) ( The Pink Sheet ) FDA: Don’t rush a move to change the Covid-19 vaccine composition ( STAT ) BioNTech, Pfizer to start testing universal vaccine for coronaviruses ( Reuters ) US Health Officials Announce New Monkeypox Vaccination Plan ...
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    Recon: EU approves two Sanofi treatments for rare diseases; Novartis to cut 8,000 staffers as part of global reorganization

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short ( The Pink Sheet ) Four months after CRL due to contaminant worries, Gilead returns to FDA for next-gen HIV drug ( Endpoints ) A decade after its first approval, FDA expands weight loss pill's label for use in adolescents ( Endpoints ) Biden and G7 nations offer funds for vaccine and medical ...
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    FDA official: Virtual audits, records requests may be sticking around

    CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...
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    Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel to advise on whether — and how — Covid vaccines should be updated ( STAT ) ( NYTimes ) ( Endpoints ) ( Fierce ) Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant ( Reuters ) FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation ( Endpoints ) Astellas’ gene therapy...
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    DIA: Experts offer advice on conducting decentralized trials

    There is an unprecedented level of support among regulators to advance the adoption of decentralized clinical trials, yet companies that undertake this mode of research need to be mindful of some of the challenges that can derail these efforts. Sponsors should keep their computer systems secure, closely adhere to patient privacy laws, as well as follow good clinical practices and adopt flexible uses of technology to ensure data can be collected remotely.   So assert...
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    DIA: Global initiative to standardize CMC quality data gaining steam

    CHICAGO – Several initiatives in the works among regulators and the pharmaceutical industry are gaining momentum to harmonize chemistry, manufacturing, and controls (CMC) information submitted in the Common Technical Document (CTD). One such effort is the formation of an industry consortium that is seeking to develop a structured content cloud-based CMC Module 3 template with input from regulators.   These plans were discussed on 20 June 2022 during the Drug Informatio...
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    FDA caught up on domestic preapproval inspections, foreign inspections still a challenge

    The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions. So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug ...