• 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...
  • FDA Looks to Extend Medical Device-focused Emergency Planning System

    The US Food and Drug Administration (FDA) is proposing to extend an information program known as the Emergency Shortages Data Collection System (ESDCS) through which it collects data on medical device shortages as part of a national counterterrorism and emergency preparedness strategy. In a 4 June Federal Register posting, FDA explains ESDCS emanated from the events of 11 September 2001 and reflects its concerns that a shortage of particular medical devices could mater...
  • 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...
  • South Korean Regulators Increase Online Data Transparency

    • 31 May 2012
    South Korea's Korean Food and Drug Administration (KFDA) has announced the re-launch of its website, which now includes consolidated drug information covering all drugs manufactured in South Korea. The website now features a sub-page, drug.kfda.go.kr , which allows for the public to "retrieve and utilize a variety of drug information," including drug safety, drug effects, drug development assistance, information on pharmaceutical excipients, drug use and more. Additiona...
  • New Bill Would Standardize Package Inserts

    A new bill introduced in the Senate on 22 May would require the US Food and Drug Administration (FDA) to propose new regulations regarding the Patient Medication Information (PMI) received by patients. The proposed legislation, S.3212- Cody Miller Initiative for Safer Prescriptions Act , was introduced by Sen. Kristen Gillibrand (D-NY), and deals with PMI patients receive when obtaining drug products from a physician or pharmacist. PMI commonly includes package inser...
  • White House Wants Agencies to Develop Mobile Technologies, Open APIs

    • 25 May 2012
    A recent memo from the White House to the heads of executive departments and agencies directs them to immediately begin implementation of a new "digital strategy" aimed at making governmental information more readily and easily accessible to citizens and stakeholders. The 23 May memo outlines the government's new information accessibility strategy, contained in an accompanying report entitled, " Digital Government: Building a 21 st Century Platform to Better Serve the A...
  • US, Mexico Announce Plan to Strengthen Regulatory Cooperation

    US Health and Human Services Secretary Kathleen Sebelius and Mexico's Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation at a meeting in Geneva, Switzerland on 22 May. Sebelius and Chertorivski were at the 65 th World Health Assembly, where both acknowledged their mutual goals in promoting public health. "It is important to strengthen the programs of regulation and surveillance of med...
  • Brazil: Anivsa Sets Confidentiality Criteria

    A notice ( Ordinance No. 748-B/2012 ) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access to Information Act, which recently went into effect.  Examples of what would be classified as non-releasable is information relating to: scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as con...
  • Brazil: Anivsa Implements Freedom of Information Law

    Greater transparency is an integral part of the reorganization of Brazil's national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its possession, other than those classified as confidential.  The Access to Information Law (Law No. 12.527/2011) establishes as a fundamental principle the constitutional right of public access to public information.  The Law is now in effect according to the ordinance ...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

    A report issued by the Government Accountability Office (GAO) has found the US Food and Drug Administration's (FDA) information technology (IT) infrastructure improvement project-a $280 million program known as the Mission Accomplishments and Regulatory Compliance Services (MARCS) program-is suffering from a cavalcade of operational deficiencies and may not be completed. The program "is intended to enhance existing applications and develop new systems that provide infor...
  • New Medical Device Guidance on Information Requests Released by FDA

    The US Food and Drug Administration (FDA) released two new guidance documents covering Section 513(g) requests for information issued under the Federal Food, Drug and Cosmetic Act (FD&C Act). Section 513(g) is the means by which industry may obtain FDA's views about the classification and the regulatory requirements for medical devices. "This guidance describes procedures for the submission, FDA review, and FDA response to requests for information with respect to t...