• FDA: New OTC Switch Paradigm Would Require New Regulations

    The US Food and Drug Administration (FDA) held a hearing on Friday, 23 March on the prospect of creating a new paradigm for switching more prescription medications to over-the-counter (OTC) status in a move it claims could "increase availability of OTC medicines" to consumers. FDA is particularly concerned about the conditions in which such an OTC switch would be warranted and how to ensure patients use a medication safely. "For example, before getting a medication, you...
  • Woodcock: Electronic Health Records Key To Helping Regulatory Professionals

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a pharmaceutical conference this week that electronic health records are key to allowing regulators to "learn more quickly of problems with medicines after they enter the market," reports The Philadelphia Inquirer . Woodcock noted the numerous issues with the current system of prescribing and tracking pharmaceutical products and their adverse even...
  • Petitions to Delay Generic Seroquel Denied

    Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...
  • Woodcock Calls for Prescription Drug Tracking System

    The US Food and Drug Administration (FDA) is calling for a prescription drug tracking system to ensure the pharmaceutical supply chain's integrity, reports The Financial Times . Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, testified before the House Energy and Commerce Committee on 8 March and called for Congress to grant FDA additional authority to secure the supply chain. "Currently there is no complete record of all parties who have b...
  • Woodcock Touts FDA Success in Drug Approval

    The US Food and Drug Administration's (FDA) Director for the Center for Drug Research and Evaluation (CDER), Janet Woodcock, testified before the House Energy and Commerce Committee on 8 March to advocate for the passage of the Prescription Drug User Fee Act ( PDUFA ) and used the opportunity to tout FDA's recent drug approval accomplishments. Woodcock, the nation's top drug regulatory official, was also happy to cite numbers showing FDA was able to approve most drugs ...
  • FDA Looking to New Paradigms for Getting Drugs to Patients More Quickly

    The US Food and Drug Administration (FDA) is evaluating whether to upend several approval pathways, including the current over-the-counter (OTC) pathway with one that emphasizes more OTC medicines available to patients with chronic conditions, reports Bloomberg . FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock said that FDA is looking to hold a public hearing in March to discuss the possibility of accelerating how ...
  • User Fee Legislation for Generics and Biosimilars Released Ahead of Hearing

    Legislation establishing the user fee programs for generic drugs and biosimilar products was introduced in the House of Representatives on 9 February . The bill, To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars (H.R. 3988) , now goes before the House Energy and Commerce Committee for markup. The Committee is set to meet on 9 February to hear testimony from numerous government and industry officials, incl...
  • Hearing on Generic, Biosimilar User Fee Acts Scheduled for 9 February

    The House Energy and Commerce Committee is scheduled to hear testimony from high ranking US Food and Drug Administration and biopharmaceutical industry officials on 9 February. The hearing, Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages , will feature Center for Drug Evaluation and Research Director Dr. Janet Woodcock, Mylan, Inc President Heather Bresch, Generic Pharmaceutical Association Vice President for Reg...
  • FDA's Bob Temple Moving from ODE-1 to Other Position

    Bob Temple, the US Food and Drug Administration's (FDA) Director of the Office of Drug Evaluation 1 (ODE-1), is fully assuming his role as Deputy Center Director for Clinical Science and giving up his role as the ODE-1 director, reports BioCentury . Temple was first promoted to the position of Deputy Center Director in November 2009, but has remained in ODE-1. Prior to ODE-1, Temple worked in the Office of Medical Policy, which oversaw the then-named Division of Dru...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...
  • FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted

    The US Food and Drug Administration (FDA) approved 30 new molecular entities (NMEs) during 2011, marking a 7-year high for the agency, according to an analysis by Bloomberg . Notable success stories include Johnson & Johnson and GlaxoSmithkline, both of which tripled their approvals from the year prior.  The entire industry, however, may stand to benefit from the 42% increase in approvals as patent expiries begin in earnest this year. Twenty-one patented me...