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  • California County to Pharmaceutical Manufacturers: Pay Up

    • 25 July 2012
    Representatives of Alameda County in California have voted to require pharmaceutical companies to assume the cost of disposing of unused medicinal products, reports The Associated Press. On Tuesday, 25 July the Alameda County Board of Supervisors voted to unanimously pass an ordinance aimed at requiring the industry to "dispose of expired and unused prescription drugs." The AP reports the legislation is the first of its kind in the US, and was passed in response to the B...
  • ICH to Minimize Role of Industry in Harmonization Process

    The International Conference on Harmonisation's (ICH) plans to implement changes to minimize the role of industry in its harmonization efforts going forward, making it the second international harmonization body this year to take efforts to exclude industry. In a 3 July statement, ICH said its Steering Committee and Expert Working Groups had "agreed on new principles of governance for robust science-based Guidelines for the review of the safety, efficacy, and quality of ...
  • As Regulatory Problems Accumulate In India, Clinical Trials Sector Looks to Flee

    Can regulatory oversight simultaneously be both too much and not enough? Such is the case of India, reports The Economic Times , whose regulated industry is protesting both its increasingly strict clinical trial regulations and the dearth of regulatory oversight practiced by the Central Drugs Standard Control Organization (CDSCO). The combination of factors is causing some manufacturers to reexamine their operations in the country, and whether it makes sense to move...
  • As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

    The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012 , a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 members of the House of Representatives. "The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act , and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilar...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...
  • Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway

    • 13 April 2012
    The Pharmaceutical Research and Manufacturers of America was an early-and controversial - supporter of the Patient Protection and Affordable Care Act (PPACA) when the legislation was being formulated. Now under the tutelage of President John Castellani, the group says it is looking to keep the legislation in place, reports Market Watch . The loss of a regulatory pathway for approving biosimilar products, said Castellani, would be a disastrous setback. Likewise a num...
  • EMA's Rasi Seeks Greater Industry Participation

    European Medicines Agency (EMA) Executive Director Guido Rasi said in remarks at an industry conference he hopes to see greater industry involvement with EMA through stakeholder forums , reports Outsourcing Pharma . "The only stakeholder that is not now in the agency is the industry, but we do have a forum where we can discuss with them and include them," said Rasi to Outsourcing Pharma . "The time is now for a higher level of engagement," added Rasi. Martin Harvey,...
  • FDA Revises MAPP for Regulatory Project Management Site Tours

    A newly-revised manual of policies and procedures (MAPP) document released by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research outlines the policies and procedures for selecting pharmaceutical companies for participation in FDA's Site Tours Program (STP) and how FDA oversees the program. FDA uses the Site Tours Program to experience the drug development process from an industry perspective, share regulatory project management informatio...
  • Generics Pharmaceutical Association Preparing to Launch Drug Shortage Program

    The Generic Pharmaceutical Association (GPhA) is planning to launch a private, third-party program to track and share information about drug shortages, according to the American Medical Association . The program, dubbed the "Accelerated Recovery Initiative," was revealed by GPhA President and CEO Ralph G. Neas during an interview with American Medical News ( AMN ) on 12 March. The program plans to "provide real-time supply and distribution information to manufacture...
  • GOP Request for White House's Healthcare Reform Negotiating Notes Could Prove Explosive for Industry

    • 26 January 2012
    Republican members of the US House Energy and Commerce Committee-the committee that oversees the US Food and Drug Administration, among other agencies-is requesting that the Obama administration turn over "internal memoranda" related to the administration's negotiations with industry groups during the formulation of the Patient Protection and Affordable Care Act (PPACA) in 2010. "The White House has consistently refused our legitimate requests for information regardi...
  • FDA Provides New Guidance for Promotional Labeling and Advertising

    The US Food and Drug Administration (FDA) released a new guidance for industry on 24 January on the placement, size and prominence of a product name in promotional labeling and advertising. The final guidance, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling , "is intended to clarify the requirements" for prescription medicinal products for both humans and animals. FDA notes that the proper use of a product's name is important in e...
  • EDMA, Eucomed Join Together to Establish Industry Federation

    European medical technology associations Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming an umbrella federation that combines their two memberships in to a united front. The move "aims to enhance the recognition of their joint membership" in Europe in order to "address common issues of interest and provide stakeholders with a comprehensive view on the latest technological advances and value-based innovations," the companies said in a pr...