• Regulatory NewsRegulatory News

    FDA issues draft guidance on dosage and administration labeling

    The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section of prescription drug labeling. Such consistency will ensure that labeling is “pertinent and understandable” to health care practitioners, said the agency.   The draft is a wholesale rewrite of an earlier guidance issued in March 2010, which has now been withdrawn. The new guidance, which is roughly triple the l...
  • This Week at FDAThis Week at FDA

    This Week at FDA: FDA signs new GMP MRA, Health Canada eSTAR pilot, and more

    Editor's note: This article has been updated to correct a link to the Federal Register. 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, FDA announced two developments that could promote international regulatory harmonization and ease some burdens for regulated industry.   On Thursday, FDA said it had signed a mut...
  • Regulatory NewsRegulatory News

    Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

    The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...
  • RoundupsRoundups

    Euro Roundup: MDCG issues guidance on in-house devices under MDR and IVDR

    The Medical Device Coordination Group (MDCG) has released guidance on how the medtech regulations apply to devices and diagnostics that are manufactured and used by health institutions in the European Union.   Such in-house medical devices are exempt from most of the provisions of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the exception being the general safety and performance requirements set out in Annex I. Howe...
  • ReconRecon

    Recon: FDA rejects Biocon insulin biosimilar; Olympus says it’s fixing issues raised by FDA at Japanese facilities

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Novel Dual Rescue Inhaler for Asthma in Adults ( MedPage Today ) FDA rejects Biocon insulin biosimilar over data, manufacturing concerns ( Fierce ) JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response ( Fierce ) Physicians group urges FDA to convene expert panel before finally approving an ...
  • RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest

    RAPS awards RAC credentials to 104 autumn 2022 examinees

    RAPS published the names of 104 professionals who earned their Regulatory Affairs Certification (RAC) during the autumn 2022 exam period. Each joins the prestigious group of more than 5,000 professionals around the world who hold at least one RAC credential .  The RAC credentials are the leading certifications for regulatory professionals in the healthcare product sector and the only accredited through the National Commission for Certifying Agencies . Professionals o...
  • Regulatory NewsRegulatory News

    FDA warns endoscope maker Olympus over quality system, device reporting issues

    The US Food and Drug Administration (FDA) announced this week it has sent warning letters to Olympus Medical Systems Corporation and its subsidiary, Aizu Olympus, in recent months for good manufacturing practice issues and medical device reporting failures for some of their endoscopes. The agency says it is working with the company, which is one of the primary suppliers of endoscopes for the US market, to ensure they are in compliance.   On 10 January, FDA’s Center for...
  • Regulatory NewsRegulatory News

    FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices

    The US Food and Drug Administration (FDA) admonished Sun Pharmaceutical Industries in a recent warning letter for a several good manufacturing practice (GMP) violations, including poor aseptic practices, inadequate cleanroom design and environmental monitoring and failure to keep manufacturing equipment clean.   These violations prompted FDA to place the firm on import alert on 7 December.   FDA inspected the firm’s Gujarat India facility from 26 April to 9 May 202...
  • Regulatory NewsRegulatory News

    Omnibus brings new advanced manufacturing programs to FDA

    The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.   The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 bud...
  • Regulatory NewsRegulatory News

    CERSI Summit: Wider use of real-world evidence continues to face hurdles

    The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect between the endpoints used by regulators and the information collected in clinical practice, according to panelists at the 2023 Innovations in Regulatory Science Summit sponsored by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).   “I wish we could get rid of t...
  • Regulatory NewsRegulatory News

    A closer look at CDER’s novel drug approvals in 2022

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a report on the 37 new drug therapies the Center approved in 2022, highlighting which had received expedited development and review status, first cycle approval, and met Prescription Drug User Fee Program Act (PDUFA) VII goal dates for acting on applications.   “We approved many drugs in 2022 for patients with few or no treatment options,” CDER Director Patrizia Cavazzon...
  • Feature ArticlesFeature Articles

    A marathon, not a sprint: Ad promo training considerations

    This article discusses a three-step approach to providing regular and ongoing advertising and promotion (ad promo) training to maximize efficiencies and elevate the review experience for cross-functional team members. The authors provide considerations for optimizing training and provide resources for use at each stage of the process.   Keywords – ad promo training resources, MLR training, PRC training   Introduction Pharmaceutical companies strive to stre...