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  • India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

    India's Central Drug Standards Control Organization (CDSCO) has finalized and released a new guideline on good distribution practices for biological products manufactured in the country. Regulators said the guideline , originally released in late September 2012 in draft form , is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process."  Guidelines on Good Distribution Practices for Biologic...
  • EMA Releases Draft Guideline on Acute Heart Failure Therapies

    The European Medicines Agency (EMA) has released a new draft guideline detailing what information it expects of sponsors developing new therapies to treat acute heart failure (AHF). The guideline , released 15 October, is intended to fill in gaps in its chronic heart failure guidance, explained EMA. AHF is composed of what EMA refers to as a "wide spectrum of symptoms and signs, accompanied by hemodynamic abnormalities and neuroendocrine activation that arise secondary...
  • Multiple Sclerosis Guideline Calls for Adaptive Approaches Based on Risk

    The European Medicines Agency (EMA) has released a draft guideline for the clinical investigation of products intended to treat multiple sclerosis (MS), a neurological disease characterized by the body attacking its own fatty myelin sheaths, disrupting and damaging the body's ability to communicate with itself. The guideline -similar in principle to most released by EMA-establishes a set of recommended approaches to clinical development, with a particular focus on study...
  • New EMA Guideline Establishes Standards for Development of Antipsychotic Therapies

    The European Medicines Agency (EMA) is out with a new guideline on conducting clinical trials for products intended to treat schizophrenia which it says addresses a number of specific issues, including study design, use in sub-populations and use of add-on and combination therapies. Schizophrenia is a highly varied psychiatric disease that EMA notes is characterized by a "heterogeneous course and symptom profile." Approximately 1% of the population is affected over the c...
  • After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...
  • EMA Draft Guidance Adds Testing Requirements for Manufacturers of Bovine Serum

    The European medicines Agency (EMA) has released a new draft guideline for manufacturers who use bovine serum when producing biologics for human consumption, adding additional testing requirements to screen for bovine viral diarrhea virus (BVDV). The 1 October draft guideline, Use of bovine serum in the manufacture of human biological medicinal products , specifically revises two sections of a 2003 guideline on the same topic: Sections 7.3.3 and 7.3.4, both of which per...
  • EMA Releases Draft Guidelines on Oral Modified Release Products and Transdermal Patches

    The European Medicines Agency (EMA) has released two new draft guidelines on, respectively, the quality of oral modified release products and transdermal patches. The two draft guidance documents replace an earlier Note for Guidance on both topics released in July 1999.  Oral Modified Release Products The first guideline, Draft guideline on quality of oral modified release products , describes how Marketing Authorization Applications (MAAs) should address ...
  • EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

    The European Medicines Agency (EMA) has released a new guideline for sponsors of products to prevent strokes in patients with non-valvular atrial fibrillation (AF). EMA notes the guideline fills a void left by other guidance documents on antiarrhythmics used to prevent AF, which do not address stroke prevention and systemic embolic events (SEE). The new guideline is specifically aimed at assisting sponsors in the clinical testing of such products, regulators said. Non-v...
  • COPD Guideline Released by EMA

    The European Medicines Agency (EMA) has released a new guideline on clinical trials conducted to assess chronic obstructive pulmonary disease (COPD) products, updating an existing guideline regulators said had grown outdated. Released 8 August, Guideline on clinical investigation of medical products in the treatment of chronic obstructive pulmonary disease is scheduled to come into effect on 1 September 2012 after more than two years in development. EMA officials sai...
  • Draft Guideline on Labeling Immunoglobulin Products Released by EMA

    The European Medicines Agency (EMA) has released a new draft guideline for sponsors of human normal immunoglobulin for subcutaneous and/or intramuscular administration pertaining to the summary of product characteristics (SmPC) required to be submitted to EMA and the European Commission. The guideline, released 31 July 2012 by EU regulators, notes sponsors of the products will be required to list different SmPCs on the product depending on whether it is intended for subc...
  • Final Guideline on Antibiotic Impurities Focuses on Manufacturing Processes

    The European Medicines Agency (EMA) has released final its final guideline on how to set specifications for impurities present in antibiotics not covered by other internationally-harmonized guidelines. European regulators note in the guidance that antibiotics produced by a fermentation process are less precise and create more product variability and impurities than do other synthetic processes. Because many of these processes-including semi-synthetic fermentation-do not ...
  • India: India's Biosimilar Guidance to Come Into Effect in August

    India's Central Drugs Standard Control Organization (CDSCO) published the final biosimilar guidance  setting forth the regulatory requirements for marketing authorization for such products on 4 July 2012. The guidance covers "similar biologics that contain well-characterized proteins" and permits the use of a reference product not authorized in India, as long as the product has been approved and marketed for at least four years. A post-marketing Risk Management Pla...