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What the 21st Century Cures Act did for Regenerative Medicine

USA - April 7 2017 Under Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (“RMAT”) designation. To obtain this…

What changes can we expect at the FDA due to the 21st Century Cures Act?

USA - January 13 2017 Additional information focusing on the patient’s experience while using an investigative drug will be included in 505b submissions. Input on the…

Alert: FDA says dietary supplements subject to strict new guidance

USA - August 12 2016 In an Alert published yesterday, I provided an update on new FDA guidance regarding dietary supplements: Dietary supplements that came on the market…

What Are the FDA’s Requirements for Biosimilar Approval?

USA - May 4 2016 In part 1, I described the state of play with regard to biologics after the FDA’s approval of its second biosimilar product Inflectra (infliximab)…

FDA Approves Second Biosimilar Drug Since the Biologic Price Competition and Innovation Act of 2009 Was Passed

USA - May 3 2016 Do we finally have clarity on the regulatory process for more biosimilars to reach the market? Now that the FDA has approved its second biosimilar…