• Regulatory NewsRegulatory News

    CDRH Instructs on Magnetic Field Interference with Shunt Systems

    Magnetic externally programmable cerebrospinal fluid (CSF) shunt valve settings can inadvertently change when at a distance of fewer than two inches from common magnetic sources such as cell phones, a US Food and Drug Administration (FDA) analysis concludes.   FDA’s Center for Devices and Radiological Health (CDRH) reports that exposure to strong magnetic fields from either external magnetic sources or magnet-containing hearing devices like cochlear implants could resu...
  • Regulatory NewsRegulatory News

    CBO Finds Major Savings in FDA Provisions of Senate Health Bill

    The Congressional Budget Office (CBO) said Tuesday that the Senate’s bill to lower health care costs will reduce the deficit by about $7.5 billion over 10 years, and the sections with US Food and Drug Administration (FDA) changes will reduce the deficit by about $4.6 billion over the same time period. It remains unknown if or when the bill, known as the Lower Health Care Costs Act , will be taken up for a vote by the full Senate. But the CBO score makes clear that ev...
  • Regulatory NewsRegulatory News

    EC Revises Drug Safety Features Q&A

    The European Commission last week issued a revised questions and answers guideline on implementing safety features for medicinal products detailed in Commission Delegated Regulation (EU) 2016/161 .   The revised document includes three new questions and answers as well as one revised answer from the previous version.   New and Revised Questions   The three new questions are covered in sections 3.7, 5.10 and 8.10, while the only revised question can be found in...
  • Regulatory NewsRegulatory News

    FDA Warns Strides Pharma for Uncontrolled Document Shredding

    The US Food and Drug Administration (FDA) warned Indian generic drugmaker Strides Pharma earlier this month over good manufacturing practice (GMP) violations at its Puducherry facility that included uncontrolled shredding of documents and inadequate investigations into out-of-specification (OOS) test results.   In a securities disclosure issued on 2 July, Strides acknowledged receiving the warning letter but said that the letter will not impact production of six FDA ...
  • Regulatory NewsRegulatory News

    FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions

    A US Food and Drug Administration (FDA) proposal to amend and repeal parts of its radiological health regulations will enable better use of resources and reduce duplication, but clarifications are needed on the recording and reporting requirements, stakeholders argue.   The comment period on the March proposed rule closed earlier this month, with letters from industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA), as well as medical organization...
  • Regulatory NewsRegulatory News

    FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

    The US Food and Drug Administration (FDA) recently opened for comment until 26 August a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized. The 10-page draft of E19, endorsed by the ICH Assembly on 3 April, is part of efforts to reduce the burden on study participants while facilitating studies that can adva...
  • ReconRecon

    Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How pharma, under attack from all sides, keeps winning in Washington ( STAT ) 2020 candidates throw punches at drug industry ( Politico ) ( BioPharmaDive ) Democrat Harris unveils plan to lower drug costs, put 'people over profit' ( Reuters ) ( The Hill ) ( Washington Examiner ) ( Harris ) Democratic chair: Medicare negotiating drug prices not moving before Au...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...
  • Regulatory NewsRegulatory News

    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
  • Regulatory NewsRegulatory News

    Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

    Rep. Mike Kelly (R-PA) sent a letter Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless questioning why insulin, which has seen dramatic price increases, is not considered a complex generic drug. If FDA were to consider insulin a complex generic, like some other peptides, drugmakers would only need to submit an abbreviated new drug application (ANDA) to win approval for a copycat product, rather than a 505(b)(2) application, which only pa...
  • Regulatory NewsRegulatory News

    FDA Looks for New Device Sterilization Methods

    Following the closures of contract sterilization facilities that prompted the US Food and Drug Administration (FDA) to alert to the potential for medical device shortages, the agency launched two public innovation challenges Monday to spur sterilization alternatives and reduce emissions.   The first innovation challenge is intended to identify methods or technologies as alternatives to ethylene oxide (EtO) sterilization, while the second innovation challenge will look ...
  • Regulatory NewsRegulatory News

    MHRA Seeks Input on Patient, Public Engagement

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday opened a twelve-week public consultation to gather input on its approach to engaging the public, patients, caregivers and health care professionals.   “We want to adopt a more systematic approach to listening to and involving patients – ensuring that the patient voice is heard when safety issues, concerning medicines and medical devices, are identified and in the licensing of new medicines,” ...