• Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • 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, ...
  • C-Path Initiative's Work on Personalized Medicine Starts to Get Results

    The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star . C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs. "The idea here is, through the creation of new tools, new meas...
  • Novartis Gets Mixed News on MS, HCV Drugs From EMA, FDA

    Swiss pharmaceuticals manufacturer Novartis AG received mixed news from European and American regulators on 18 April, with the European Medicines Agency (EMA) approving its multiple sclerosis drug GIlenya with some additional warnings, and the US Food and Drug Administration (FDA) demanding a phase III trial for its hepatitis C drug alisporivir be halted after safety concerns were raised. EMA's decision on GIlenya came after some concerns about the drug's safety were r...
  • House Meets to Discuss PDUFA, MDUFA User Fees

    • 18 April 2012
    The House Energy and Commerce Committee is meeting 18 April starting at 10:15 AM to discuss various proposed user fee agreements, including the Prescription Drug User Fee Act (PDUFA)  and the  Medical Device User Fee Act (MDUFA)  reauthorization bills on 18 April. The hearing, entitled "US Food and Drug Administration User Fees 2012: How Innovation Helps Patients and Jobs," will be taking place at room 2123 of the Rayburn House Office Building. A webcast...
  • Cosmetic Regulation Under Review in Congress

    The House Energy and Commerce Committee is slated to review the safety and regulation of cosmetics in a hearing scheduled for 27 March. The hearing intends to explore the possibility of establishing national standards for cosmetic ingredients, which the Committee writes "would serve to further public health by ensuring these decisions are made using sound science and ensure that the interstate flow of cosmetic products is not disrupted by differing State standards." "U...
  • FDA Releases PMA Summaries for Q4 2011

    The US Food and Drug Administration (FDA) is updating its list of available safety and effectiveness summaries of Premarket Approvals (PMAs) to include all decisions made in the fourth quarter of 2011. The updated list includes the PMA docket number, applicant, trade name of the product and the product's approval date, as well as the complete safety and effectiveness summary by FDA. All 15 products added to the list during the 4 th quarter of 2011 were approved. Under...
  • Hearings to Explore Budget, Prescription Drug Issues

    A trio of Congressional hearings the week of 27 February will explore the proposed budget of the US Food and Drug Administration (FDA), the proposed budget of the US Department of Health and Human Services (DHHS) and prescription drug diversion. On 29 February 2012, FDA Commissioner Margaret Hamburg will appear before the US House Committee on Appropriations . Hamburg will be joined by FDA Assistant Commissioner for Budget Patrick McGarey and Deputy Assistant Secretary ...
  • Implementation of Medical Device Recall Authority Sought by FDA

    The US Food and Drug Administration (FDA) announced on 10 February that it is seeking to implement its medical device recall authority under § 518(e) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Chapter 21, Section 810 of the Code of Federal Regulations (CFR). Section 518(e) allows FDA to order manufacturers to cease distribution of a device and notify health professionals if FDA finds a "reasonable probability that the device intended for human...