Breakthrough Therapy or Fast Track Designations
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Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients since 1988. Through highly qualified and experienced personnel located in offices across North America, Europe, Israel, and South Africa, supported by strategic alliances with selected regional CROs, CATO offers tried-and-trusted international coverage.
CATO has the advantage of integrated regulatory, clinical, and scientific expertise. Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 postmarketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutriceuticals, medical foods, devices, and diagnostics. In terms of diseases and indications, CATO has been involved in a wide variety of projects with a dominant focus in oncology, neurology/CNS, and rare and orphan drug indications. This experience includes leadership of, and involvement in some of the most challenging and innovative products.
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Mallinckrodt plc (NYSE:MNK) today announced it has entered into a licensing agreement for development and commercialization of NeuroproteXeon’s investigational, pharmaceutical-grade xenon gas for inhalation therapy being evaluated to improve survival and functional outcomes for patients resuscitated after a cardiac arrest.
Cato Research Blog
Complicated Drug Product? FDA Releases New Draft...
by Cato Research on July 23, 2019 at 8:27 pm
Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance […]
New FDA Guidance’s For May 2019
by Cato Research on June 14, 2019 at 2:32 pm
Special Interest Guidances/Information Date Posted Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff – Final Guidance 30 May 2019 Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for […]