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E4 Pharmaceutical Consulting

E4 Biotechnology and Pharmaceutical Consulting. Providing product development (CMC), regulatory, QA/QC and project management support to companies developing new small-molecule drugs, biologics and medical devices.

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E4 Pharmaceutical Consulting

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RSS FDA News

  • FDA to Weigh Options for Importing Single-Source Drugs
    FDA Commissioner Scott Gottlieb announced Thursday that the agency will consider allowing imports of some drugs that have seen major price increases in the United States.
  • Woodcock Outlines Reorganization of CDER Offices
    CDER Director Janet Woodcock released details of a major overhaul of four CDER offices Thursday aimed at improving the center’s ability to respond to new priorities.
  • FDA Issues Draft Recommendations on Submitting Field Alert Reports
    The investigation should be based on factors specific to the distributed product, including dosage, the agency said.
  • FDA Says Biosimilar Sponsors Should Include Reference Product on Labeling
    The proprietary name should be used in sections that cover risks and warnings of adverse events, such as boxed warnings, contraindications and the “drug interactions” section.
  • FDA Urges Drug Sponsors to Ensure Data is ‘Interoperable or Integrated’
    The agency urged sponsors to use EHR or EDC systems so the relevant information “may be entered once at the point-of-care and used many times without manual re-entry or manual source data verification.”

RSS Pharma Times

  • Be recognised for the part you play in targets being met
    Ongoing training and development is key to a happy, motivated sales force and now, the PharmaTimes Sales Awards has a category dedicated to the people who make it happen.
  • Industry shows support for new Medical & Scientific Excellence Awards
    News of the inaugural Medical & Scientific Excellence Awards has got the industry talking, with a number of entries already received.
  • Want to make a difference? Enter the new Charity Challenge
    PharmaTimes media is partnering with Bowel Cancer UK and Beating Bowel Cancer to launch a Charity Challenge Award as part of the Communications Team of the Year competition.
  • Fly your company's flag - ENTER NOW
    With just six weeks to go until the prestigious PharmaTimes Marketer of the Year closes for entry, marketers at all levels of their career are looking forward to taking part in the 25th anniversary celebrations.
  • Sub-cutaneous form of Entyvio hits PhIII safety, efficacy goals
    Takeda says it has late-stage trial results showing the benefit of an investigational subcutaneous formulation of Entyvio to patients with ulcerative colitis.
  • Kisqali wins speedy US breast cancer nod
    Novartis’ Kisqali has been approved for breast cancer in the US less than one month after being filed with the US Food and Drug Administration.
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