• Feature ArticlesFeature Articles

    How the Role of Regulatory Operations Professionals Will Evolve in the new Decade

    This article introduces forward-looking trends that may affect how the role of regulatory operations professionals will progress over the next 10 years. Regulatory operations professionals from three biopharmaceutical companies also share their perspectives on the changing regulatory landscape and emerging challenges.   Introduction   Regulatory operations professionals face a much different world from the one they did 10 years ago, as novel therapy development inc...
  • RoundupsRoundups

    Asia Regulatory Roundup: China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Opens Regulatory Fast Track to Manufacturers of Coronavirus Equipment   China’s National Medical Products Administration (NMPA) is fast tracking the processing of requests to manufacture and sell face masks and other pieces of medical equipment capable of slowing the spread of the coronavirus.   NMPA has created the fast track to encourage manufacturers of ...
  • Regulatory NewsRegulatory News

    Updated: Czech Notified Body Yet to Apply Under MDR as Others Prep for Post-May Designations

    As the European Commission updated its NANDO database on Thursday to unveil the 10 th notified body designation under the Regulation (EU) 2017/745 (MDR), other notified bodies designated under the outgoing 93/42/EEC Medical devices (MDD) told Focus they are either awaiting designation or did not apply. Some but not all notified bodies under MDD have offered updates on their websites as to the progress with their designations under MDR, and  Focus reached out to seve...
  • Regulatory NewsRegulatory News

    Interview With FDA’s OND Director: Approval Standards, Transparency and More

    Peter Stein, director of the US Food and Drug Administration’s (FDA) Office of New Drugs (OND) sat down with Focus at FDA’s White Oak campus for an exclusive interview to discuss some of the criticism FDA has received in recent months with regard to the pace of its drug approvals and the possible lowering of its approval standards.   Stein also discussed signing off on Sarepta Therapeutics’ Duchenne’s muscular dystrophy injection Vyondys 53 (golodirsen) in December, ...
  • Regulatory NewsRegulatory News

    FDA’s OPQ, OCP Tout 2019 Highlights in New Reports

    Two offices within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), the Office of Pharmaceutical Quality (OPQ) and Office of Clinical Pharmacology (OCP), as well as the Division of Applied Regulatory Science within OCP, highlighted achievements on Monday within their 2019 annual reports.   OPQ   OPQ’s 2019 annual report is the third released since the office was established in 2015. Highlights include that OPQ participated...
  • Regulatory NewsRegulatory News

    Tracking and Tracing Drugs and Vaccines: WHO Drafts New Policy

    The World Health Organization (WHO) is seeking comments on a draft policy to help guide national regulators seeking to use international harmonized standards for creating systems to track and trace pharmaceuticals and vaccines through their supply chains. The policy is part of efforts to help already stretched regulators minimize the risk of substandard and falsified (SF) medical products, shortages and expired products. WHO discusses seven common features of traceab...
  • Regulatory NewsRegulatory News

    Trump’s 2021 Budget Request Seeks Modest Funding Increase for FDA

    The Trump administration on Monday unveiled its FY 2021 budget proposal, seeking a 10% reduction in overall funding for the Department of Health and Human Services (HHS), but a slight increase in funding for the US Food and Drug Administration (FDA). For FDA, the budget requests $6.2 billion overall, including $3.3 billion in discretionary budget authority (BA) and $2.9 billion in user fees. Steven Grossman, deputy executive director of the Alliance for a Stronger F...
  • ReconRecon

    Recon: Roche, Lilly Alzheimer’s Drugs Fail in Phase II/III Study; WHO Coronavirus Advance Team Arrives in China

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche, Lilly drugs fail to halt gene-driven Alzheimer's disease ( Reuters ) ( WSJ ) ( Roche ) ( Lilly ) FDA hands Gilead a nice CAR-T boost as critics pounce on underwhelming Q4 call and Twitter buzzes with M&A chatter ( Endpoints ) ( Press ) FDA approves AI-based software that helps doctors take ultrasound pictures of the heart ( STAT ) ( MedtechDive ) ( FDA )...
  • Regulatory NewsRegulatory News

    Industry Groups Pitch FDA on Upcoming Clinical Outcome Assessments Guidance

    In response to the US Food and Drug Administration’s (FDA) public workshop on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision-making last December, industry groups have submitted suggestions for what the agency’s upcoming guidance on the topic should cover.   Background   The workshop was the fourth in a series held by FDA to meet its commitments under the latest reauthorization of the Prescription Drug User Fee Amendme...
  • ReconRecon

    Recon: AbbVie Boosts 2020 Outlook; Novacyt Seeks Emergency Authorization for Coronavirus Test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First US attempt at CRISPR gene editing in cancer appears safe ( Reuters ) ( Science Mag ) ( Science ) ( Endpoints ) Scott Gottlieb adds one more high-profile board seat to the post-FDA resume. And it’s another plum assignment ( Endpoints ) ( Press ) Biotech company Novacyt seeks emergency approval for coronavirus test ( Reuters ) AbbVie boosts 2020 outlook de...
  • Regulatory NewsRegulatory News

    Coronavirus: Senators Call on FDA to Ensure Supply of Products From China is Safe

    As the number of infections and deaths from the novel coronavirus (2019-nCoV) outbreak in China continue to rise, US Sens. Marco Rubio (R-FL) and Chris Murphy (D-CT) on Thursday called on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to ensure the safety of the drugs and medical devices imported from China.   In a letter to Hahn, the senators point out that the US imported more than $12 billion in food, drugs and medical devices from China in 2018 and...
  • Regulatory NewsRegulatory News

    FDA Classifies NGS HIV Drug Resistance Test Into Class II

    The US Food and Drug Administration (FDA) on Thursday issued a final order classifying next generation sequencing (NGS) HIV drug resistance genotyping assays used to aid in monitoring and treating HIV infections into Class II (special controls).   The final order follows a de novo classification request from Vela Diagnostics for its Sentosa SQ HIV Genotyping Assay last March and a decision in November to place the device into Class II. The final order on Thursday als...