• 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...
  • Device Innovation Pathway Tackles End-stage Kidney Disease

    The US Food and Drug Administration (FDA) has selected three medical devices being developed for end-stage kidney disease for participation in its new Innovation Pathway , which provides the sponsors of the devices the opportunity to work collaboratively with the agency.  The goal of the Pathway is to reduce the time and cost of bringing safe and effective, breakthrough devices to patients. The three devices selected for the end-stage kidney disease initiative are:...
  • FDA Opens Innovation Pathway to First Round of Devices

    The US Food and Drug Administration (FDA) is announcing its intention to open up its experimental Innovation Pathway to three medical device companies developing therapies for end stage renal disease (ESRD). FDA's 9 April announcement said the three organizations-CreatiVasc Medical, Blood Purification Technologies Inc. and the University of California-were among 32 product applications covering a wide range of applications.  "The response from innovators exceeded...
  • Bill Looks to Make Changes to FDA's Accelerated Approval Pathway

    • 05 April 2012
    A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration's (FDA) Accelerated Approval pathways, reports The Hill . Among other things, the bill would "create a new 'breakthrough' designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions," reports The Hi...
  • 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 ...
  • New Bipartisan Bill to Expand Accelerated Approval Pathway

    [Updated 6 March to Include Link to FAST Act.] An upcoming piece of legislation advanced by Reps. Cliff Stearns (R-FL) and Edolphus Towns (D-NY) would expand the US Food and Drug Administration's (FDA) use of the accelerated approval pathway , reports BioCentury . The Faster Access to Specialized Treatments (FAST) Act is reportedly similar to Sen. Kay Hagan's (R-NC) bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act ,...
  • CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science

    The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012.  The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives. CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant infor...
  • ULTRA Bill Introduced in the House Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for 'Ultra Orphan' Drug Approvals

    • 03 January 2012
    Two congressmen have introduced legislation that would amend the Food, Drug and Cosmetic Act to provide an easier, accelerated approval pathway for drugs for "Ultra Orphan" diseases, which affect fewer than 6,000 people.  In comparison, "Orphan Diseases" affect fewer than 200,000 individuals. The bill, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA) (H.R. 3737), would allow for surrogate endpoints that is "reasonably likely, based on epidemiologic,...