• Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

    • 12 October 2012
    The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors. The remarks, reported by Bloomberg , potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new pr...
  • In Wide-Ranging Interview, Hamburg Looks Back on First Four Years as Commissioner

    US regulators are increasingly reaching out to partner with their foreign counterparts, transitioning from a domestic agency to one with a global focus, said US Food and Drug Administration (FDA) Commissioner Margaret Hamburg in a lengthy appearance sponsored by the Center for Strategic and International Studies (CSIS). Hamburg's 1 October appearance at CSIS was meant to be a retrospective look at the commissioner's four-year tenure as head of the agency, and she offer...
  • FDA Given New Authority to Oversee Clinical Trials Data Reporting

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement . Under section 801 of the Public Health Service Act (PHSA) , as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institut...
  • Hamburg: Device Approvals Process Set to Become Less Burdensome

    The head of the US Food and Drug Administration (FDA) thinks the approval process for medical devices is about to become considerably smoother thanks to the passage of the Medical Device User Fee Amendments ( MDUFA ), reports the Minneapolis Star Tribune . Hamburg was attending an August 2012 meeting with Sens. Al Franken (D-MN) and Amy Klobuchar (D-MN) and representatives from the medical device industry regarding the pace at which FDA regulators are approving me...
  • Report: Monitoring Scandal Involves Top FDA Officials

    Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports The Wall Street Journal . The Journal's 7 August report highlights for the first time the involvement of FDA Commissioner Margaret Hamburg, the top official at the US regulatory agency, who was reportedly briefed on the surveillance program shortly after the initiat...
  • Pressure Mounts on FDA Over Surveillance Scandal

    The US Food and Drug Administration (FDA) is facing mounting pressure from both Congress and outside groups after The New York Times published an exposé on a clandestine monitoring program at the agency. The entire case stems from a report in January 2012 by The Washington Post , which revealed that a group of former FDA medical reviewers had filed a lawsuit against the agency for allegedly intercepting communications between them and outside oversight entities...
  • FDA Approves Landmark HIV Prevention Pill

    The US Food and Drug Administration's (FDA) drug regulatory division announced the approval of a new indication for Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate), making it the first drug with an approved indication to prevent the transmission of the Human Immunodeficiency Virus (HIV). The drug was first approved in August 2004 under priority review for the treatment of existing HIV. FDA said under the new indication, approved 16 July 2012 via a supple...
  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...
  • Senate Passes FDA User Fee Legislation, Bill Now Moves to White House

    In an expected development, the US Senate on Tuesday (26 June) voted overwhelmingly to approve the Food and Drug Administration Safety and Innovation Act (FDASIA) , advancing the bill to the White House where it is expected to receive approval from President Barack Obama in July. The 92-4 vote followed months of negotiating between the House of Representatives, the Senate, the US Food and Drug Administration (FDA), the pharmaceutical industry, the medical device i...
  • Government Report Blames Drug Shortages on FDA, Calls for Change in Warning Letter Policy

    • 18 June 2012
    A new report released by the Chair of the House Oversight Committee, Representative Darrell Issa (R-CA), blames the US Food and Drug Administration (FDA) for an "unprecedented" series of dug shortages which has had a particularly pronounced effect on cancer patients. In the report, FDA's Contribution to the Drug Shortage Crisis , Issa claims that while others have attributed the causes of the shortages to a "myriad of factors"-raw materials shortages, market concentrati...
  • Hamburg Continues to Call for More Anti-Counterfeiting Authority

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg remains adamant the agency needs more authority to go after counterfeiters . For the third time in as many months, Hamburg has spoken out publicly in an attempt to garner more attention for what she sees as a lack of legal and regulatory "teeth" to address the problem of fake and substandard drugs entering the US' pharmaceutical supply chain. Speaking on Wednesday, 7 June to The Financial Times , Ham...
  • New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies

    The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast cancer can obtain treatment, say experts. The guidance, released on 28 May,  is "intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic co...