• UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the  diagnosis and management of chronic hepatitis B in children, young people and adults , explaining that only pegylated interferon and nucleoside or nucleotide analogues have been cleared for use by the National Health Service (NHS). The guideline, released for consultation on 17 January 2013, also noted that although substantial pr...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...
  • Legislators Press FDA to Release Agency Materials Related to Meningitis Outbreak

    Republican legislators with the House's Energy and Commerce Committee, the committee charged with overseeing the US Food and Drug Administration (FDA), now say the agency has until 30 November to acquiesce to their demands for access to internal documents related to a recent outbreak of fungal meningitis. The Energy and Commerce Committee's subcommittee on health has been investigating an outbreak of fungal meningitis, now understood to have been caused by contaminated...
  • Final Guidance for Blood Product Testing Released by FDA

    The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it hopes will assist in the screening of blood and plasma donors for the virus. The final guidance comes nearly a year after the agency first released the draft version of the guidance . FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and a...
  • Groups, FDA Announce Launch of New Clinical Data Standards Harmonization Partnership

    The US Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) have announced the formal launch of a new clinical data standards consortium known as the Coalition for Accelerating Standards and Therapies (C-FAST). Both CDISC and C-Path are data organizations which set many of the global standards used to report data from clinical trials. The partnership between all three organizations w...
  • FDA Marks Half-Century of Regulation Based on Safety, Efficacy

    A half-century ago today, the US Food and Drug Administration (FDA) experienced perhaps its greatest expansion of regulatory authority since its inception, allowing it to regulate pharmaceutical products based not only on the safety of a product but their efficacy as well. That authority, granted by the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1938, came in the wake of an international regulatory crisis involving Thalidomide, a drug in...
  • Consortium Brings Together FDA, Industry to Release New Data Reporting Standard

    Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies. The new tool is set to be used to standardize the way companies report data from research on drug regimens intended to treat tuberculosis (TB), a bacterial...
  • Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

    A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape. The Stop Tampering of Prescription Pills Act of 2012 , introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]." Such a product ...
  • New Regulatory Data Standards Partnership Formed to Accelerate Research

    A new partnership between two regulatory organizations supported by the US Food and Drug Administration (FDA) has the potential to accelerate clinical research and medical product development, the groups said in a statement. In a 21 June statement, the Clinical Data Interchange Standards Consortium (CDISC) and the Critical path Institute (C-Path), announced the formation of a partnership with FDA to develop new data standards, tools and methods to guide the development o...
  • 'Misleading' Patient Perspective Smacked Down by FDA in Untitled Letter

    One pharmaceutical company is learning this week that reproducing a patient's story to "mentor" other potential patients may not sit well with US regulatory authorities, regardless of whether it represents the patient's perspective accurately. Cambridge, Massachusetts-based manufacturer Vertex Pharmaceuticals was sent an Untitled Letter by the US Food and Drug Administration (FDA) warning it about its promotion of Incivek (teleprevir), a Hepatitis C (HCV) drug which FD...
  • FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs

    The US Food and Drug Administration (FDA) has released final guidance for industry to assist sponsors looking to develop drugs to treat patients suffering from irritable bowel syndrome (IBS). The 30 May guidance, Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment , covers general IBS symptoms and addresses two sub-sets of IBS which primarily result in diarrhea (IBS-D) and constipation (IBS-C), which FDA said have unique consi...
  • Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, CGMP, Design Deficiencies

    The US Food and Drug Administration (FDA) released five warning letters previously issued to companies in the healthcare product sector, including three medical device companies, one pharmaceutical distributor and one supplement manufacturer. William Demant Holdings A/S (Medical Device) FDA's warning letter to William Demant , a Danish medical device manufacturer, cited deficiencies at its Oxford, UK facility found during two December 2011 inspections. The company, w...