• Regulatory NewsRegulatory News

    A look at FDA’s data on priority and competitive generics

    Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations. The FDA Reauthorization Act of 2017 (FDARA), which reauthorized GDUFA for five years, includes provisions to shorten the reviews of certain ANDAs...
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    Inspections down in 2020, but CDER hit most goal dates

    During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals mandated by its various user fee programs – and, generally, the agency succeeded, though a steep drop in inspections hampered some efforts.   The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 3...
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    Recon: Pfizer working on COVID vaccine booster; J&J expects data on its COVID vaccine next week

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden sets sights on 1.5 million vaccinations a day ( Politico ) Pfizer working on booster shot to protect against COVID-19 variants: Bloomberg ( Reuters ) Pfizer to Deliver US Vaccine Doses Faster Than Expected ( Bloomberg ) Johnson & Johnson expects details on COVID-19 vaccine trial next week ( Reuters ) ( CNBC ) FTC sues drug makers over allegedly illegal ...
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    WHO updates COVID vaccine and clinical care guidelines

    The World Health Organization (WHO) has released recommendations that include the use of low-dose anticoagulants for hospitalized patients with COVID-19 to reduce the risk of venous thromboembolism. That recommendation accompanies four other updates to the agency’s “living guidance” document for clinical management of patients with COVID-19.   For inpatients, the specific anticoagulation regimen recommended is thromboprophylaxis-level dosing rather than intermediate or...
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    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

    The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published its procedure for conducting remote compliance inspections related to drugs and regenerative medical products.   PMDA set out its approach to remote inspections late last year, before going on to post an English translation of the document last week. The document details the different steps of the remote inspection process and what applicants can do to prepare.   PMDA will inform an applic...
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    Australia’s TGA authorizes Pfizer COVID vaccine

    The Therapeutic Goods Administration (TGA) on Monday granted provisional approval to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for individuals aged 16 and older, making it the first COVID-19 vaccine authorized for use in Australia.   The approval follows a provisional determination by the agency in October allowing for the submission of the application under the provisional pathway. TGA has also granted provisional determinations for vaccines developed by Astra...
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    Stakeholders weigh in on big data at EMA forum

    Effective use of real-world data and other data gathered outside the clinical trial arena requires a unified, big-picture approach, according to a new report from the first-ever big data stakeholder forum held by the European Medicines Agency (EMA).   The regulator’s report on the 15 December 2020 forum highlighted the importance of collaboration in addressing some of the challenges of bringing real-world data (RWD) into the drug development process. Some of these incl...
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    OPDP's Gray reflects on 2020's challenges, successes

    Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.   Speaking in a “Conversations” interview hosted by FDA’s Center for Drug Evaluation and Research, Katie Gray, PharmD, spoke of inter-agency initiatives to encourage biosimilar competitiveness, how the pandemic changed the year’s course for OPDP, and future directions.   In th...
  • ReconRecon

    Recon: Merck stops development of COVID vaccines; Moderna developing booster against new COVID variants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck ends COVID vaccine program, cites inferior immune responses ( Reuters ) ( Endpoints ) ( STAT ) Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses ( NYTimes ) ( Politico ) US goal to squeeze more COVID shots from Pfizer vials hampered by syringe production ( Reuters ) Moderna says it believes vaccine will work against new variants ( Reuters...
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    Federal charges levied against COVID "vaccine" peddler

    Federal criminal charges have been filed against a man previously warned by the FDA for peddling unproven and unauthorized “vaccines” against COVID-19.   Johnny Stine, president of Oregon-based North Coast Biologics, previously received a May 2020 warning letter jointly issued by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). In the letter, the agencies ordered him to cease “misrepresentations” made on Facebook and LinkedIn, as well a...
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    Brexit, medicine availability top EMA stakeholder report

    Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.   The EMA report , released Friday and covering the 2018-19 biennium, was presented to EMA’s Management Board in December 2020. It provides a high-level look at interaction between the European regulator and the pharmaceutical indu...