• Regulatory NewsRegulatory News

    FDA seeks ‘legislative solution’ for LDT oversight

    In the wake of a New York Times investigation into non-invasive prenatal testing (NIPT), the US Food and Drug Administration (FDA) told Republican lawmakers that it would welcome legislation to enable greater oversight of NIPTs and other laboratory developed tests (LDTs).   The Times investigation , published early last month, found that some NIPTs that screen for microdeletions that are offered to hundreds of thousands of pregnant women each year frequently give f...
  • Regulatory NewsRegulatory News

    CBER warns Massachusetts-based CRO over GLP issues

    A warning letter to Massachusetts-based contract research organization (CRO) Toxikon Corporation earlier this month details good laboratory practice (GLP) violations during the conduct of a nonclinical study.   The warning letter comes just months after the company was acquired by Labcorp and lists multiple GLP violations uncovered during a month-long inspection last summer.   According to the warning letter, the company’s study director failed to assure that all...
  • Regulatory NewsRegulatory News

    QMSR: FDA proposes QSR overhaul after years of delays

    Four years after the US Food and Drug Administration (FDA) signaled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016, the agency on Tuesday issued a proposed rule laying out its vision for the long-awaited regulatory overhaul.   The resulting regulation would be dubbed the Quality Management System Regulation (QMSR). According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 mi...
  • Regulatory NewsRegulatory News

    OPDP’s first warning letter of 2022 targets CytoDyn for COVID claims

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a rare warning letter – its first for 2022 – to CytoDyn after the company posted a video interview last September of its then-CEO Nader Pourhassan that included promotional statements about the company’s investigational COVID-19 treatment leronlimab.   The letter was sent just weeks after the company’s board of directors terminated Pourhassan’s employment and appointed Anton...
  • Regulatory NewsRegulatory News

    This Week at FDA: QSR meeting, Woodcock’s new role, 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. This week, we learn that FDA is convening its external expert group on medical device GMPs to discuss its plan to align the Quality System Regulation (QSR) with the international standard, ISO 13485:2016. We also look at the some takes on what Robert Califf will face as FDA commissioner t...
  • Regulatory NewsRegulatory News

    Senate confirms Califf as FDA commissioner

    Three months after his nomination by President Joe Biden, and despite weeks of uncertainty over whether he could muster enough Republican votes to overcome Democratic defectors in a narrowly split Senate, Robert Califf was confirmed as commissioner of the US Food and Drug Administration (FDA) for the second time on Tuesday in a 50-46 vote.   The vote came after the confirmation cleared a procedural hurdle on Monday, in which five Republicans joined most Democrats in ...
  • Regulatory NewsRegulatory News

    Generic industry raises issues with FDA’s cover letter checklists

    The generic drug industry says it wants reassurances that the cover letter attachments detailed in a recent US Food and Drug Administration (FDA) draft guidance are truly optional and won’t be held against applicants if they are not included or are incomplete.   The industry comments are in response to a draft guidance on cover letter attachments for controlled correspondences and abbreviated new drug application (ANDA) submissions that was issued for comment in Dece...
  • Regulatory NewsRegulatory News

    This Week at FDA: FDA postpones VRBPAC, QSR on the horizon, and Califf’s upcoming vote

    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. This week, we look at the breaking news that FDA is postponing its upcoming advisory committee meeting to review Pfizer and BioNTech’s request to authorize their COVID-19 vaccine in children 6 months through 4 years of age. We also saw FDA’s proposal to harmonize its Quality System Regula...
  • Regulatory NewsRegulatory News

    FDA officials, advisors cast doubt on foreign-only clinical strategy

    The US Food and Drug Administration (FDA) raised serious concerns about Eli Lilly and Innovent’s biologics license application (BLA) for the companies’ PD-1 inhibitor sintilimab during an extraordinary meeting of its Oncologic Drugs Advisory Committee (ODAC) on Thursday.   “Today’s ODAC will not follow the traditional paradigm of assessing the benefit-risk profile of a single drug; rather, the concept of generalizability and applicability of single-country foreign data...
  • Regulatory NewsRegulatory News

    FDA would rather not have to review ‘sanitation tunnels’ for COVID

    In an unusual move, the US Food and Drug Administration (FDA) on Tuesday publicly discouraged sponsors from developing or seeking a regulatory nod for “sanitation tunnels” or other similar walkways or chambers intended to reduce the spread of COVID-19.   FDA explained that these tunnels were first deployed in China and have been developed in other countries outside the US and are typically placed outside of “crowded places such as food markets, shopping malls, hospital...
  • ReconRecon

    Recon: GSK sees sales growth in 2022; EMA sets up new real-world data center

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO says chances are ‘very high’ FDA will approve low-dose Covid shots for kids under 5 ( CNBC ) Pfizer’s 2022 outlook falls short of Wall Street’s lofty expectations ( FT ) CVS expects 70%-80% drop in COVID vaccine administration in 2022 ( Reuters ) CVS inks a deal with Medable to enroll more patients in clinical trials ( STAT ) Purdue Pharma bankrupt...
  • Regulatory NewsRegulatory News

    This Week at FDA: Inspections restart, Califf making the rounds, 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. This week, we look at some of the emerging news impacting Robert Califf’s nomination to be FDA commissioner, plus some new reports from FDA on drug safety, clinical pharmacology, and its strategic priorities for CDRH.   Earlier today we heard from an FDA official that the agency will ...