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    The PhD scientist’s pathway into regulatory affairs

    Making a transition from a life and health science research scientist to a regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.   Intellectual curiosity is often the impetus for pursuing a doctorate degree (PhD). The desire to learn a su...
  • Draft Guidance Calls for Lengthier Premarket Safety Databases for Rheumatoid Arthritis Treatments

    The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the development of pharmaceutical and biological products meant to treat rheumatoid arthritis, a painful and debilitating autoimmune disease that affects a patient's mobility. Background Rheumatoid arthritis has been something of a minefield for FDA and industry in the last decade. In 2004, pharmaceutical giant Merck voluntarily withdrew its blockbuster drug Vioxx, a non-ster...
  • Pfizer's Tofacitinib Wins Regulatory Approval Ahead of PDUFA Date

    • 07 November 2012
    After a lengthy back and forth, Pfizer's potential rheumatoid arthritis blockbuster Xeljanz (tofacatinib) has won approval from the US Food and Drug Administration (FDA), the agency announced on 6 November. Rheumatoid arthritis (RA) is a disease in which the body's immune system attacks otherwise healthy tissue, causing joint and tissue swelling and damage. Xeljanz is expected to fill a large niche market for patients with RA who did not respond to methotrexate, also...
  • Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

    The US Food and Drug Administration (FDA) said Pfizer is withdrawing an indication for its rheumatoid arthritis (RA) drug Celebrex after Pfizer indicated it would not be able to complete a mandated postmarketing study to verify the new indication. Celebrex had received approval for its indication to treat familiar adenomatous polyposis (FAP) in 1999 under FDA's accelerated approval pathway. The inherited condition causes polyps to form in the large intestine, often causi...