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Need a patent fast? Try track one

USA - January 15 2016 Track One expedites the examination of a patent application. Once granted, the USPTO strives to reach a final disposition within 12 months.When can…

FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence

USA - May 17 2019 On May 8, 2019, FDA issued draft guidance for the submission of documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs…

FDA Final Guidance on Application of Statutory Factors in Determining When a REMS is Necessary

USA - April 11 2019 On April 4, 2019, FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and mitigation…