• FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

    • 17 July 2012
    The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...
  • MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

    Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in th...
  • Will EMRs Drive Adoption of New Software Synchronization Abilities?

    • 06 June 2012
    Keeping all of the time pieces in one's house synchronized represents a challenge to even the most obsessive of timekeepers. Most devices-clocks, cell phones, cable boxes, cars and more-include an internal or external clock to improve, track or coordinate functions. So when hospitals multiply those devices by a few thousand, keeping them synchronized doesn't just represent a challenge-it represents a threat to patient safety, claims a new study. The Economist report...
  • MHRA Releases New Guidance for Impending Changes to Labeling Regulations

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is announcing the launch of new guidance to assist sponsors looking to comply with the terms of new regulations set to change how sponsors can label their products. Under the terms of the Better Regulation of Medicines Initiative ( BROMI ), MHRA is taking a more targeted approach to how it regulates medicines by re-focusing its resources on higher-risk activities. One of the numerous changes to be imple...
  • Proposed Legislation Would Allow for Conditional Clearance of Medical Devices

    • 01 June 2012
    A new piece of legislation introduced in the House of Representatives on 30 May by Rep. Bruce Braley (D-IA) would give the US Food and Drug Administration (FDA) additional oversight of medical device recalls and allow certain medical devices to receive conditional clearance from the agency. Braley's bill, the Medical Device Patient Safety Act , is similar to a piece of legislation of the same name introduced in December 2011 in the Senate by Sens. Charles Grassley (...
  • AHRQ Looking to Establish Registry of Patient Registries

    • 30 April 2012
    The US Agency for Healthcare Research and Quality (AHRQ), the federal agency charged with improving how healthcare dollars are spent, is announcing its intention to launch a registry of patient registries modeled after of its ClinicalTrials.gov website. AHRQ explains in its Federal Register posting that patient registries, typically run by disease-specific foundations, have "specific characteristics" that the ClinicalTrials.gov website has not been able to adequately c...
  • Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up

    • 20 April 2012
    Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...
  • FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making

    The US Food and Drug Administration is announcing its intent to hold a meeting on how best to involve patients, patient advocacy groups and health professional groups in regulatory decision-making. The meeting, FDA's first Patient Network program Annual Meeting entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges," is being hosted by FDA's Office of Special Health Issues and will be held on 18 May 2012. FDA said in a statement, "the meetin...
  • MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making "procedural changes" to the process by which sponsors of marketing authorization applications (MAAs) submit full-color mock-ups of labels and patient leaflets. In its new guidance, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications , MHRA notes several changes, including:...
  • Study: Cancer Trial Leaflets Too Long, Confusing to Patients

    • 28 March 2012
    A study published in the journal Sociology of Health and Illness claims patient information leaflets used to inform patients interested in participating in clinical trials are "too long, incomprehensible, and even intimidating," reports Medical News Today . The study looked at the information sheets of 13 cancer trials, and recruited 26 patients associated with the trials to provide additional feedback on their experiences. "These information sheets are poorly aligne...