Tag Archives: Administration

  • Pharmaceutical Consultants Broaden the Scope

    … Finally, all of the Administration’s efforts to improve the Nation’s capacity to respond quickly and effectively to the next influenza pandemic should be closely monitored by the White House, especially by the staff of the National Security Council. (xii) This passage evokes images of high-ranking generals and government officials huddled closely together, brandies at their elbows and cigar smoke hanging heavily in the air, hammering out strategies, tactics, and counter-measures. Now, is …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … for and stored. These things are normally checked: -Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports -Totality of accountability documentation for the receipt, storage, Administration, and return of test article (drug, device, etc.) -Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor -Aptness of the informed consent process -Timely and …

  • The Future of Influenza Vaccine Design

    … the construction of virus particles that undergo only a single cycle of replication.  These induce a protective antibody response and stimulate a strong cell-mediated immune response without allowing the replication of infectious virus. 5.    DNA vaccination This involves the Administration of plasmid DNA encoding one or more of the influenza virus proteins.  Studies have been limited to animal samples with very promising results; however, this type of vaccine may be better for diseases …

  • And the H1N1 Vaccine’s Surprises Keep Rolling

    … and Review at the Food and Drug Administration, stated that this situation does not create a safety issue because every lot had passed the pre-release testing required to ensure safety, purity, and effectiveness.  He maintained that the loss of effectiveness was a slight one. The thirteen lots that were withdrawn were a part of 4.7 million doses of the intranasal vaccine, whose origin is a live weakened virus; however, officials think that the majority of these were administered during October …

  • CDER’s Small Business Assistance Bulletin

    … pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via the ListServ 1. New Guidance. The Food and Drug Administration announced in a Federal Notice of December 23, 2009, the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.’’ The guidance was prepared under the …

  • FDA’s Response to a Developing Pandemic

    In preparation of a developing pandemic of any kind, whether it be influenza, or some other kind of fast spreading virus, the Food and Drug Administration (FDA) has devised a precautionary plan known as the FDA Pandemic Preparedness Strategic Plan.  The FDA Pandemic Preparedness Strategic Plan is coordinated with the President’s National Strategy for Pandemic Outbreaks, as well the CDC’s Pandemic Implementation Plan.  Under these guidelines the FDA works under federal and local levels to …

  • How Do Pharmaceutical Companies Develop Value in These Current Times?

    … about safety, marketing statements that are not true, and the threat of the government’s increasing role on the purchasing and pricing of drugs. The healthcare reform has been at the center of the public eye, but drug companies have remained in the background.  In return for promising the Obama Administration they would contribute $80 billion in savings to aid in the financing of the proposed reform, the industry’s basic pricing structure would not be touched by the restructuring.  …

  • Pharmaceutical Industry Contributes to Future of Personalized Medicine

    … collaborative effort amongst government and international agencies such as the FDA (Federal Drug Administration) and NIH (National Institute of Health). Drug and genetic test manufacturers and health care providers also need to work together to implement tests and therapies. One of the biggest leaders fighting the personalized medicine cause is SAEC (Serious Adverse Events Consortium). Along with the FDA, SAEC unites government agencies, academic institutions and pharmaceutical companies. Their …

  • FDA Resolves Compliance Issues with Drug/Device Combination Products

    … produced by different manufacturers. Another issue that arises is the complexity of drug/device combinations. Combined products could be as simple as a syringe pre-filled with drugs. They also could be as complex as chemotherapeutic drugs combined with monoclonal antibodies. The U.S. Federal Drug Administration (FDA) has made it a top priority to address these ongoing compliance issues. They developed the Office of Combined Products (OCP) which was a result of the Medical Device User Fee and …

  • International Pharmaceutical Companies Make Global Impact on H1N1 Vaccine

    It’s a race against time as international pharmaceutical companies develop this life-saving vaccine for the deadly H1N1 influenza virus. The U.S. Food and Drug Administration recently approved four H1N1 vaccines. Pharmaceutical consulting firms point out that the H1NI vaccines are similar to the seasonal flu vaccines. However, the current seasonal flu vaccines on the market do not protect people from the H1N1 virus. The FDA will continue to conduct clinical studies to determine the proper …

  • How to Develop New Employee Orientation Programs for GXP Compliance

    … manufacturing practice), task-specific technical training should be saved for the department/unit level.  However, according to the GMP the following domain (context) specific should be included: •    OSHA (Occupational Safety and Health Administration) regulations •    MSDS (Material Safety Data Sheets) •    GXP regulations and compliance information The following regulatory regimes should also be discussed: •    FDA (Federal Drug Administration) •    DEA (Drug …

  • FTC Releases Report on “Follow-on Biologic Drug Competition”

    … concludes that providing the U.S. Food and Drug Administration (FDA) with the authority to approve such FOBs would be an efficient way to bring these lower-priced drugs to market. “If Congress creates an efficient pathway to follow-on biologic drugs and, at least as important, ends ‘pay-for-delay’ pharmaceutical settlements that delay entry of traditional generic drugs, it will be taking a major step forward for both health care reform and affordable drugs for all Americans,” said FTC …