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Join FDAnews Tuesday, April 17, for "How to Write and Maintain Bulletproof Company Core Data Sheets: 5 Best Practices for Streamlining Global Safety and Label Reporting." In this 90-minute interactive audioconference, A. Michael Bloh, R.Ph., will examine the importance of company core data sheets (CCDSs) in pharmacovigilance and drug safety compliance and show you how to write SOPs that include procedures for CCDSs. On April 18, join RxTrials Institute and FDAnews for "Recruitment and Retention in Clinical Trials: What Works, What Doesn't and Why." In this 90-minute audioconference with Q&A session, Christine Pierre walks you through studies examining the top motivators and de-motivators for enrollment. Then on April 19, join FDAnews for "Negotiating An FDA Import Hold: Strategies for Challenging FDA Findings." In this 90-minute interactive audioconference, attorney Dara Katcher Levy will show what FDA and Customs officials look for when examining a shipment, as well as explain who to talk to at the FDA and what to say.
Boca Pharmacal announced that the FDA granted final approval to the company's abbreviated new drug application (ANDA) for its generic version of Panlor SS.
Neurochem announced it has received notification from the FDA that the action date for the agency's review of the new drug application (NDA) for Kiacta has been rescheduled from April 16 to July 16.
Pro-Pharmaceuticals announced that the FDA has responded in a letter to the company's questions related to the submission of its new drug application (NDA) for Davanat.
Cell Therapeutics has announced that Xyotax, a biologically enhanced version of Taxol, has been granted fast-track designation for the treatment of poor-performance status women with first-line, advanced, non-small-cell lung cancer (NSCLC).
Vical has announced that a seasonal influenza vaccine formulated with its Vaxfectin adjuvant generated up to 60-fold higher antibody responses than an unformulated vaccine at the same dose in a recently completed study in mice.
An influenza vaccine produced with the use of insect cells appeared safe and produced an immunogenic response in healthy adults, suggesting promise as an alternative to using embryonated eggs for the development of influenza vaccine, according to a preliminary study published in the April 11 issue of The Journal of the American Medical Association (JAMA).
CoMentis has announced the initiation of a Phase II clinical study of ATG3, the company's topical therapy for wet age-related macular degeneration (AMD).