• Regulatory NewsRegulatory News

    FDA's COVID therapeutics, mAbs guidance accounts for variants

    As the world rolls into year 2 of the COVID-19 pandemic, regulators and drug developers are grappling with how to address variant strains of SARS-CoV-2 as they bud and expand globally.   The inevitable path for RNA viruses is to mutate, a fact acknowledged by Janet Woodcock, MD, acting commissioner US Food and Drug Administration, in a Monday press conference announcing the availability of new and updated guidance for developers of therapeutics, vaccines, and tests for...
  • Regulatory NewsRegulatory News

    OPDP warns Paragard maker over promotional video

    A sponsored video that aired on NBC’s Boston affiliate in October has landed CooperSurgical a warning letter from the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) for failing to include risk information about the company’s Paragard intrauterine device (IUD).   The warning letter is the second sent by OPDP in 2021 and is the second enforcement letter sent to CooperSurgical concerning Paragard. In 2019, OPDP sent the company an unt...
  • RoundupsRoundups

    Asia-Pacific Roundup: Australia, Japan authorize COVID vaccines

    Australia and Japan have granted emergency authorizations to COVID-19 vaccines. The Australian Therapeutic Goods Administration (TGA) cleared AstraZeneca’s vaccine, while its Japanese counterpart gave the green light to Comirnaty, the vaccine from Pfizer/BioNTech.   The TGA decision authorizes the  COVID-19 Vaccine AstraZeneca for use in Australia for the next two years. In that time, TGA expects AstraZeneca to provide it with longer-term safety and efficacy data from ...
  • Regulatory NewsRegulatory News

    FDA’s OCP 2020 report highlights achievements post-reorganization

    The US Food and Drug Administration’s (FDA’s) Office of Clinical Pharmacology has issued its 2020 report, highlighting the office’s contributions to drug development, research, policy and communication.   Describing the COVID-19 pandemic as the “personal and professional challenge of a lifetime,” Issam Zineh, PharmD, MPH, Director of the Office of Clinical Pharmacology (OCP), said OCP staff met the moment during a global public health crisis by creating “strike teams t...
  • ReconRecon

    Recon: Drugmakers tell Congress vaccine supply to increase in March; Pfizer accused of playing hardball in Latin American vaccine negotiations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J ready to ship nearly 4 million doses of COVID-19 vaccine in US ( Reuters ) ( Politico ) Pfizer to ship 13M COVID-19 vaccine doses per week to US by mid-March, says executive ( Reuters ) FDA to allow Pfizer-BioNTech vaccine to be stored at standard freezer temps ( Reuters ) ( NYTimes ) Moderna says FDA gave positive feedback on request to increase Covid vac...
  • Regulatory NewsRegulatory News

    COVID test developers get variant-related FDA guidance

    A new guidance from the US Food and Drug Administration (FDA) provides considerations for developers of molecular, antigen and serology COVID-19 tests as they evaluate how viral mutations may affect test performance.   As variants in the SARS-CoV-2 virus emerge and spread, FDA has been monitoring mutations tracked in global databases and checking to see whether mutations are occurring in regions of the virus genome that various molecular tests target, explained the age...
  • Regulatory NewsRegulatory News

    FDA unveils plans to tackle COVID variants

    The US Food and Drug Administration (FDA) on Monday unveiled recommendations for vaccine, drug and diagnostic test developers to address the impact of COVID-19 variants on the efficacy and performance of their products.   The recommendations are made across four new and updated guidances targeting vaccines , drugs and biologics , monoclonal antibodies and diagnostic tests .   “The purpose of these guidances is to address the emergence and potential future emer...
  • Regulatory NewsRegulatory News

    FDA updates EUA guidance, addressing vaccines against COVID variants

    The US Food and Drug Administration (FDA) has revised its guidance for developers of vaccines against COVID-19 as regulators and health authorities assess the need to adjust vaccines so they remain effective as new SARS-CoV-2 variants emerge.   For the time being, developers can expect to conduct immunogenicity studies for vaccines to address these variants that will enroll “on the order of few hundred individuals in terms of size,” said Peter Marks, MD, PhD, director ...
  • ReconRecon

    Recon: Novavax completes enrolment in US COVID vaccine trial; Sanofi to help manufacture J&J vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax completes enrolling 30,000 people in US trial of COVID-19 vaccine ( Reuters ) AstraZeneca to withdraw Imfinzi US indication for advanced bladder cancer ( Reuters ) ( Endpoints ) Pfizer promises to double supply as Biden pushes for quicker vaccine rollout ( Reuters ) US administers 63.1 million doses of COVID-19 vaccines: CDC ( Reuters ) Who Will Be th...
  • Regulatory NewsRegulatory News

    FDA: Oximeters may be inaccurate in Black patients

    The US Food and Drug Administration (FDA) has issued a new safety communication about the limitations of using pulse oximeters to assess blood oxygen levels. The communication is based in part on findings that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.   The agency’s communication comes in the context of the COVID-19 pandemic, which “has caused an increase ...
  • Regulatory NewsRegulatory News

    EMA plots earlier engagement with patient groups

    The European Medicines Agency’s (EMA) on Friday announced it will pilot an early engagement program to bring patient and consumer groups to the table with its human medicines committee earlier in the evaluation process.   In its proposal for the pilot, EMA says there are “missed opportunities” for its Committee for Medicinal Products for Human Use (CHMP) to incorporate patient perspectives into its reviews, as patient input is typically sought late in the process and o...
  • Feature ArticlesFeature Articles

    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...