• RAPSRAPS' Latest

    Why Kim Young joined the RAPS’ staff and why she wants you to email her

    Since she first got involved with RAPS in the mid-1990s, Kim Young has been a mainstay among our organization’s rapidly growing European membership. In October 2022, Kim joined RAPS as its first full-time European employee. As our Regional Engagement Director in Europe, Kim won’t just be on the ground at RAPS’ European events . She’ll also be around virtually to help chapters, local networking groups and members get the most out of their RAPS memberships — and to ...
  • Regulatory NewsRegulatory News

    AdvaMed sets out its priorities for new Congress

    As the 118 th Congress gets underway, the medical device lobby group AdvaMed is focused on ensuring that lawmakers prioritize issues such as diagnostics reform and Medicare coverage for breakthrough devices. AdvaMed CEO Scott Whitaker said that the group is working with multiple legislators to achieve their objectives.   Last year, AdvaMed spent much of its effort lobbying Congress to pass the Medical Device User Fee Amendments (MDUFA V) and the Verifying Accurate Lea...
  • Regulatory NewsRegulatory News

    FDA details approach for finding optimal dosages for new cancer drugs

    The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical development and in it, the agency recommends a new approach in selecting such dosages for modern, targeted oncology drugs.   Historically, dose-finding trials for cytotoxic chemotherapy drugs have been designed to determine the maximum tolerated dose (MTD). The MTD paradigm applies to drugs that have a steep dose-response, have...
  • Regulatory NewsRegulatory News

    Expert: Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers

    Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for companies as they develop new devices headed for the less stringent US Food and Drug Administration (FDA) review pathway, an industry expert says.   The studies – Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance , and Use of Recalled Devices in New Dev...
  • ReconRecon

    Recon: FDA approves Luye’s long-acting schizophrenia drug Rykindo; EU proposes changes to pharma law to avoid shortages

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Entering J&J’s fiefdom, Luye wins FDA approval of long-acting schizophrenia drug ( Fierce ) ( Pharmaphorum ) Reversing abortion drug's approval would harm public interest, U.S. FDA says ( Reuters ) Orphan Drug Exclusivity Remains a Priority in 2023, Says FDA Deputy Commissioner ( FDAnews ) FDA’s Biosimilar Regulatory Science Pilot Launches With Five Projects (...
  • RoundupsRoundups

    Asia-Pacific Roundup: WHO warns on contaminated cough syrups linked to child deaths

    The World Health Organization (WHO) has published a medical product alert about contaminated cough syrups linked to the deaths of 18 children in Uzbekistan. Marion Biotech, an Indian business, is the stated manufacturer of both products.   In late 2022, the Uzbekistan Ministry of Health announced the results of its investigation into DOK-1 Max, a syrup used to treat cold and flu symptoms. Preliminary laboratory studies found the syrup contained ethylene glycol, a conta...
  • Regulatory NewsRegulatory News

    Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics

    The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...
  • Regulatory NewsRegulatory News

    FDA looking externally and internally to develop future IT leaders

    The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more efficient. According to a top agency official, some of the work is already underway as the agency looks internally and externally for future IT leaders.   For years, the FDA has dealt with decentralized IT systems that were unable to work w...
  • Regulatory NewsRegulatory News

    FDA draft guidance covers low-level light therapy devices

    The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are typically used for aesthetic or dermatologic uses, such as to treat cold sores. While some light-emitting products pose low risks to users and fall under the agency’s general wellness devices policy, others can pose a high enough risk to users for the agency to consider them regulated medical devices.   FDA ...
  • ReconRecon

    Recon: FDA, CDC link Pfizer’s bivalent COVID booster to possible strokes in older adults; Eisai files for Japanese approval of Alzheimer’s drug Leqembi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Bivalent Shot Shot Linked to Stroke in One Safety Database ( Bloomberg ) ( MMWR ) ( Reuters ) Novo Nordisk's GLP-1 for Type II diabetes approved for first-line treatment ( Endpoints ) ( Biospace ) AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales ( Fierce ) David Kessler, Biden official key to covid vaccine effort, steps down...
  • RAPS AnnouncementsRAPS Announcements

    RAPS arrives in India

    The Regulatory Affairs Professionals Society (RAPS) is bringing a networking group for regulatory professionals to India, making it the first—but certainly not the last—community for the profession on the subcontinent. RAPS is committed to uniting the full global regulatory community in education, knowledge-sharing and career development. With this expansion, RAPS now boasts 33 chapters and local networking groups spanning six continents. “What I look forward to from th...
  • Regulatory NewsRegulatory News

    FDA official says pandemic reauthorization bill could drive VALID across finish line

    A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more data about the supply chain to prevent future shortages.   For several years, FDA has sought explicit authority from Congress to regulate laboratory-developed tests (LDTs). Despite bipartisan support last year for the Verifying Accurat...