• Regulatory NewsRegulatory News

    FDA sets CDISC implementation timeline

    The US Food and Drug Administration (FDA) will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 March.   The 4 March announcement in the Federal Register comes soon after a 21 February deadline for applying to participate in a fit-for-use pilot designed to test the new clinical data exchange standards. (RELATED: Participants sought for FDA nonclinical data exchan...
  • ReconRecon

    Recon: Moderna taps Baxter to fill 60-90M vaccine doses; NHS strikes deal for Novartis’ Zolgensma

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche joins AstraZeneca in ditching bladder cancer indication for immunotherapies ( Reuters ) ( Endpoints ) ( Press ) Moderna taps Baxter to support fill and finish of 60-90 million COVID-19 vaccine doses ( Reuters ) Government Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Vaccines ( WSJ ) ( Reuters ) Merck says study shows COVID-19 drug causes ...
  • Feature ArticlesFeature Articles

    Advantages of developing and deploying an in-house regulatory intelligence database

    Companies with a global regulatory presence may benefit from developing an in-house regulatory intelligence database. Such a database can be customized to focus on key subjects by building content reflecting published sources and the company’s experience. Adaptable content for multiple uses can be built by the company’s local experts. The system structure must support diverse users to create, maintain, document, access, and understand the information with functional collab...
  • Regulatory NewsRegulatory News

    Trials without clinical sites offer chance for improved access, generalizability

    The COVID-19 pandemic has fueled the rise of clinical trials without clinical sites and opened the door to continuing these innovative models after the public health crisis has faded. While these trials offer the potential to expand access and the generalizability of results, there are also some limitations to conducting drug trials in this format.   In a special communication in  JAMA Internal Medicine , Steven R. Cummings, MD, director of the San Francisco Coordina...
  • ReconRecon

    Recon: Canada authorizes J&J COVID vaccine; FDA cautions on fever scanner accuracy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock Interview on COVID-19 Tests and Vaccines ( NPR ) What to look for in Lilly’s eagerly awaited Alzheimer’s data ( STAT ) Abbott's test to distinguish coronavirus and flu viruses gets US authorization ( Reuters ) FDA approves Roche’s Actemra/RoActemra treatment for rare lung disease ( Pharmafile ) San Diego Zoo apes get an experimental animal vaccine ag...
  • Regulatory NewsRegulatory News

    COVID-19: FDA offers guidance on container closure switches

    The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.   With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems ...
  • Feature ArticlesFeature Articles

    A multiprong approach to organizational regulatory intelligence: One company’s experience

    It is important and of value for organizations to establish a dedicated regulatory intelligence (RI) function and process with designated roles and responsibilities to support RI monitoring. The true value is realized when there is commitment and engagement across the organization to build the RI resource. This article will lay out how one process was defined for regulatory surveillance/ monitoring (which relies on communication, cross-functional team engagement, and a rob...
  • ReconRecon

    Recon: Amgen buys Five Prime for $1.9B; EU investigating Teva over Copaxone practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden convenes bipartisan meeting on cancer research ( The Hill ) ( Reuters ) Amgen spends $1.9 billion on Five Prime, eyeing an expansion in Asia ( STAT ) The $14 million CEO: Drug distributor boosts executive’s pay despite historic opioid settlement ( Washington Post ) Pfizer’s Lorbrena scores expanded FDA approval for first-line NSCLC ( PMLive ) ( Endpoints...
  • Regulatory NewsRegulatory News

    PDUFA VII negotiations continue as industry presses for clear timelines

    As meetings continue between the US Food and Drug Administration (FDA) and industry to negotiate the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA VII), cell and gene therapy demands and timelines continue to loom large. Minutes from this and other end-of-year PDUFA subgroup meetings continue to show how industry and FDA are working to balance commitments and resources for PDUFA VII.   In a 17 December 2020 breakout meeting, representativ...
  • Regulatory NewsRegulatory News

    FDA unveils data modernization plan

    A three-pronged plan to modernize the US Food and Drug Administration’s (FDA) approach to data was unveiled Wednesday, building on the agency’s previous technology modernization effort.   In a blog post announcing the new Data Modernization Action Plan (DMAP), Acting FDA Commissioner Janet Woodcock and Principal Deputy Commissioner Amy Abernethy write that data modernization is the “next step” for the agency after its 2019 Technology Modernization Action Plan (TMAP)...
  • RoundupsRoundups

    FDA Approvals Roundup: Nulibry, Amondys 45, Pepaxto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nulibry okayed to cut mortality risk in babies with rare genetic disorder Origin Biosciences’ Nulibry (fosdenopterin injection) has been approved for reducing the risk of death from molybdenum cofactor deficiency (MoCD) type A, a rare, genetic metabolic disorder marked by severe seizures. The condition presents soon after birth and most patients...
  • ReconRecon

    Recon: Merck to conduct new trial of OncoImmune COVID drug; NIH halts convalescent plasma trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says will have enough COVID-19 vaccine for every U.S. adult by May ( Reuters ) ( NYTimes ) Biden calls on states to prioritize vaccinations for teachers ( Reuters ) White House using Defense Production Act to equip Merck plants for J&J vaccine ( Reuters ) ( NPR ) ( Fierce ) White House taps insurers to boost vaccinations among vulnerable communities ( Po...