• Regulatory NewsRegulatory News

    FDA "rapidly" finalizing EUA for J&J vaccine, following adcomm thumbs up

    In a unanimous vote, an advisory committee to the US Food and Drug Administration (FDA) has recommended authorization of the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson.   The 22-0 vote endorsing a favorable benefit-risk profile for the vaccine represents the third positive decision on a COVID-19 vaccine – but the first unanimous one – from FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). In a statement that came...
  • Regulatory NewsRegulatory News

    FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

    The US Food and Drug Administration (FDA) on Thursday updated the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine to allow the vaccine to be transported and stored at temperatures found in conventional pharmaceutical freezers for up to two weeks.   The announcement comes one week after Pfizer and BioNTech disclosed they had submitted data demonstrating their vaccine’s stability at higher temperatures based on manufacturing data from the p...
  • Regulatory NewsRegulatory News

    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
  • RoundupsRoundups

    FDA Approvals Roundup: Libtayo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Libtayo gets extended indication for NSCLC with high PD-L1 expression Regeneron’s Libtayo (cemiplimab-rwlc injection) has been approved as a first-line therapy for locally advanced non‒small cell lung cancer (NSCLC) in patients whose tumors have high programmed death-ligand 1 expression established by an FDA-approved test. The patients should ...
  • Regulatory NewsRegulatory News

    FDA targets remdesivir, thymosin in compounding concerns

    The US Food and Drug Administration has updated information on compounding drugs during the COVID-19 pandemic, focusing on some specific compounded drugs related to COVID-19.   “FDA has concerns about the use of certain drugs prepared by compounders to treat COVID-19,” wrote the agency on its web page addressing compounding during the pandemic.   The first drug called into question by FDA is thymosin-alpha 1. “The agency is aware of drug products containing thymo...
  • 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...
  • 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...
  • 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 ...
  • 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 ...