• Regulatory NewsRegulatory News

    HHS OIG criticizes FDA’s foreign inspection program in new report

    T he US Department of Health and Human Services’ Office of Inspector General (OIG) asserted in a new report that the US Food and Drug Administration’s (FDA) practice of preannouncing foreign inspections, inadequate documentation of investigator training and its slow pace at issuing warning compromise the agency’s foreign inspections program.   However, the OIG found that the agency improved in some areas after implementing programmatic changes in 2017, such as its f...
  • Regulatory NewsRegulatory News

    Drugmakers seek details on use of ctDNA as a biomarker or early endpoint

    Drug developers are asking the US Food and Drug Administration (FDA) for more details on definitions, methodologies, and use cases for employing circulating tumor DNA (ctDNA) as a biomarker or an early endpoint in early-stage solid tumor clinical trials.   FDA issued draft guidance on the topic in May 2022, including ctDNA for patient selection based on molecular alteration, ctDNA molecular residual disease for patient enrichment and ctDNA as a measure of response. T...
  • Regulatory NewsRegulatory News

    Recon: Senate report says AbbVie sheltered profits from US taxes; Merck in talks to acquire Seagen for $40B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug ( Endpoints ) ( STAT ) ( Reuters ) Senate Report Hits AbbVie’s Bermuda Tax Structure for U.S. Humira Sales ( WSJ ) ( Washington Post ) Mylan Pharmaceuticals faces another recall on insulin injection pens ( Endpoints ) US government warns health and pharma co...
  • RoundupsRoundups

    Euro Roundup: EMA finalizes companion diagnostic guidance

    The European Medicines Agency (EMA) has finalized guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA and the notified body in the conformity assessment process.   As part of conformity assessments, notified bodies need to seek a scientific opinion on the suitability of the companion diagnostic for use with the concerned medicinal product from either EMA or a competent authority. Notified bodies should consult with EM...
  • Regulatory NewsRegulatory News

    Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

    Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals .   Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the ...
  • Regulatory NewsRegulatory News

    European Commission adopts common specifications for high-risk IVDs

    The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR).   The Commission explains that harmonized standards do not exist for certain class D IVDs, “and there is a need to address public health concerns as the risk associated with the use of those devices is significant for public health and patient safety.” ...
  • Regulatory NewsRegulatory News

    Health policy experts call for stronger accelerated approval reforms

    The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, according to a perspective article from three experts on drug regulation and health policy.   The perspective, written by Rachel E. Sachs, JD, MPH, of Washington University in St. Louis, Julie M. Donohue, PhD, of the University of Pittsbur...
  • ReconRecon

    Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA decision on Eisai, Biogen Alzheimer's drug due in January ( Reuters ) ( Fierce ) ( The Pink Sheet ) ( Bloomberg ) NBC pundit, public health expert Vin Gupta in line for top Biden administration spot ( Politico ) Roche’s Lunsumio eyes year-end FDA verdict to be first bispecific for non-Hodgkin lymphoma ( Fierce )  ( Pharmaphorum ) Coherus, Junshi’s Cancer C...
  • 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...
  • ReconRecon

    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...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA updates uniform recall procedure

    Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the agency expects to receive in relation to recalls.   Deletion of the section on crisis management guidelines is notable. In version 2.2, TGA urged sponsors to implement the guidelines “as quickly as possible and ensure that appropriate p...
  • This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, 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. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...