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  • Regulatory NewsRegulatory News

    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • Regulatory NewsRegulatory News

    Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
  • Regulatory NewsRegulatory News

    House proposes $3.2 billion for FDA in FY 2021

    On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a markup session for fiscal year 2021 appropriations.   Of the total budget of $23.98 billion – a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the Food and Drug Administration (FDA). This amount is an increase of $40.8 million over the prior fiscal year’s approximate $3.2 bill...
  • Regulatory NewsRegulatory News

    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
  • Regulatory NewsRegulatory News

    Radiologists to FDA: Autonomous AI not ready for prime time

    Artificial intelligence is not ready for autonomy in radiology, according to two radiological professional associations who asked the US Food and Drug Administration (FDA) to wait for more rigorous testing and surveillance of the modality before authorizing its autonomous implementation in medical imaging.   In follow-up to a February 2020 workshop focused on artificial intelligence (AI) in medical imaging, the chairs of the American College of Radiology (ACR) and th...
  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Regulatory NewsRegulatory News

    FDA: Digital safety data submission to supplant PDFs

    After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.   The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make oth...
  • Feature ArticlesFeature Articles

    Regulatory Focus, June issue: Nutrition in health and disease management

    This month marks the fifth anniversary of the annual series on nutrition in health and disease management, initiated in 2016 by Manfred Ruthsatz , PhD, RAC, FRAPS (executive director, Nutrition+HealthCARE, Switzerland). Ruthsatz has led all five series to date, this year, together with co-lead, Andrea Wong , PhD (SVP, scientific and regulatory affairs, Council for Responsible Nutrition, Washington DC). They have coordinated authors and reviewers who are global leaders in...
  • Regulatory NewsRegulatory News

    Guidance: FDA holds off on enforcing certain UDI requirements

    The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking.   In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Devi...
  • Regulatory NewsRegulatory News

    Pediatric anti-infective development addressed by FDA

    The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.   The draft guidance notes that pediatric drug development in general comes with some challenges, including the fact that differences not only in body size but also organ maturation and body fluid composition and distribution can affect drug pharmacokinetics and pharmacodynamics in children. Also, some infect...