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    Senate Bill Seeks to Create Standards Body for Regenerative Medicine

    Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies. The bill, known as the Advancing Standards in Regenerative Medicine Act , would require the US Food and Drug Administration (FDA) to oversee the creation of a "Standards Coordinating Body" for regenerative medicine. Regenerative medicine and advanced therapies belong to a growing field of medicine that i...
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    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
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    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
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    German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation

    The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive . Background and 2012 Conclusion Stem cell transplantation is a therapy used to treat certain cancers, immunodeficiencies and hematologic diseases. It has also been widely used to treat multiple myeloma. Patients undergoing stem cell transplantation a...
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    FDA Willing to Accept Different Endpoints When Assessing Lung Cancer Drugs

    Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week. The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics , is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC d...
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    FDA Updates Adverse Event Reporting Requirements for Tissue, Cellular Products

    When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US Food and Drug Administration (FDA) makes clear, cellular and tissue products are also subject to reporting requirements. Background The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps. ...
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    FDA Outlines Regulatory Exemptions for Use of Cell, Tissue Products

    A new guidance document issued by the US Food and Drug Administration (FDA) is trying to clarify the differences between tissue products and procedures which fall under the agency's regulations, and those products and procedures which do not. Background FDA regulates tissue products—otherwise known as human cell, tissue or cellular or tissue-based products (HCT/Ps)—under Chapter 21, Section 1271 of the Code of Federal Regulations (21 CFR 1271). Specifically, FDA regul...
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    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • Cell and Gene Therapy Guidance Finalized by FDA, Calls for Early and Frequent Communication

    The US Food and Drug Administration (FDA) has announced the final release of a guidance intended to clarify the processes by which cellular and gene therapy (CGT) products should be assessed prior to human testing. Background CGTs are essentially used to make therapeutic changes to a person's cells, tissue or genes by injecting a patient with altered DNA, cells or entire organs. The products include cellular therapies, gene therapies, therapeutic vaccines, xenotransplan...
  • FDA Extends Comment Period on Cell and Gene Therapy Guidance by Six Months

    Manufacturers of cell therapy (CT) and gene therapy (GT) products will have six months of additional time to comment on a July 2013 draft guidance released by the US Food and Drug Administration (FDA), regulators announced today. Background In July 2013, FDA's Center for Biologics Evaluation and Research (CBER) released a draft guidance it said would help industry in designing early-stage clinical trials for CTs and GTs. The guidance was specifically aimed at investiga...
  • Draft Guidance on Cell, Gene Therapy Products Establishes General Framework

    The US Food and Drug Administration (FDA) has release a new draft document aimed at providing guidance on the preclinical assessment of cellular, tissue and gene (CTG) therapy products. CTGs are essentially used to make therapeutic changes to a person's cells, tissue or genes by injecting a patient with altered DNA, cells or implanted with organs. The products include cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation and other drug products, i...