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    FDA finalizes instructions for use guidance for drugs, biologics

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the content and format of Instructions for Use (IFU) labeling for pharmaceutical manufacturers to help consumers understand complicated instructions for using a drug or a biologic.   The guidance covers human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA)....
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    Recon: FDA delays decision on Beigene drug due to COVID restrictions; Pfizer seeks Japanese approval for COVID vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis, BeiGene’s PD-1 drug the latest to hit FDA wall as pandemic stalls another review ( Fierce ) ( Reuters ) FDA again spells out safety concerns with oral type 1 diabetes drug while denying Lexicon's attempt to overturn a CRL ( Endpoints ) In post-Roe guidance, HHS tells 60,000 pharmacies: Don't stop dispensing abortion drugs ( Endpoints ) ( Reuters ) Ab...
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    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
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    Recon: CDC says pandemic drove US deaths from antibiotic resistant superbugs; Biden officials mulling expanding second booster to all adults

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US deaths from antibiotic resistant 'superbugs' rose 15% in 2020 ( Reuters ) ( Washington Post ) Biden officials push to offer second booster shots to all adults ( Washington Post ) ( Bloomberg ) White House to prioritize boosters, testing for Omicron BA.5 subvariant ( Reuters ) 'Approvability has been put to bed': Aldeyra says eye drop clears three dry eye si...
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    Proposed legislation takes aim at prescription drug advertising

    New legislation recently introduced in the House of Representatives would direct the US Food and Drug Administration (FDA) to finalize a long-dormant final rule requiring pharmaceutical manufacturers to include a statement on drug labeling warning of a drug’s risks and side effects “in a clear, conspicuous, and neutral manner.”   The Banning Misleading Drugs Act , introduced by Rep. Abigail Spanberger (D-VA) on 5 July, would require FDA to “finalize a 15-year old prop...
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    Personalized medicine growth hindered by outmoded drug development paradigm

    There has been explosive growth in the number of applications and approvals for personalized medicines, yet the current drug development paradigm is not optimizing the development of these treatments, asserted Kenneth Getz, the executive director of the Tufts Center for the Study of Drug Development (CSDD).   Getz told Regulatory Focus in a 7 July interview that over the past 20 years, there has been unprecedented growth in the number of personalized development ther...
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    Recon: FDA to review first OTC birth control pill; EU recommends second COVID booster for over-60s

    In Focus: US Drugmaker seeks FDA approval of over-the-counter birth control pill ( STAT ) ( Reuters ) ( Washington Post ) FDA grants full approval to Pfizer COVID vaccine for ages 12-15 ( Reuters ) Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half ( The Pink Sheet ) In wake of unexpected patient deaths, MacroGenics closes down PhII cancer trial ( Endpoints ) Drug Pricing Plan Faces Industry Gripes as Senate Reconvenes ( Bloombe...
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    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...
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    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...
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    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...
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    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...