• Consumers Groups Attack FDA Over De Novo Process

    A group of 12 consumer groups is chastising the US Food and Drug Administration (FDA) for approving what they perceive to be 'high-risk' medical devices through FDA's de novo approval pathway . In a letter to FDA Commissioner Margaret Hamburg sent 29 February, the groups, including Consumers Union and Public Citizen, said that FDA's use of the de novo pathway was setting a bad precedent. "Medical devices intended to save lives should require FDA's most rigorous saf...
  • FDA Releases Most Recent Accounts of MDUFA Negotiations, Unveils Upcoming Regulations

    The US Food and Drug Administration (FDA) released a cache of meeting minutes from the February negotiations over the Medical Device User Fee Act (MDUFA) reauthorization language. The minutes give a timely look in to the negotiations over what many deem must-pass legislation. The minutes also give insight into future FDA medical device regulation. Minutes from the 17 February negotiations indicate that FDA is committed to exempting " additional low risk medical devi...
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    Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible

    Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures...
  • FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

    The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising. The study , Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements , was conducted in response to a proposed...
  • Draft Guideline Released on Assessing Risk of Advanced Therapy Medicinal Products in Europe

    The European Medicines Agency (EMA) released a new draft guideline on 24 January assessing Advanced Therapy Medicinal Products (ATMPs) using a risk-based approach. ATMPs are biological medicinal products such as gene therapy, somatic cell therapy or tissue-engineered products. According to EMA , ATMPs contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replac...
  • EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

    The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance. The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics). Accurate knowledg...