News & Press

Neil Singla, MD- Public Comments on FDA’s February 2022 Draft Guidance for Industry

Below please find my comments on FDA’s draft document: Development of Non-Opioid Analgesics for Acute Pain: Guidance for Industry, dated February 7, 2022. I am a board-certified anesthesiologist and Chief Scientific Officer of Lotus Clinical Research, LLC, a contract research organization, regulatory consulting firm and research site network specializing in analgesic clinical trials.

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Press Release: Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

Lotus Clinical Research worked closely with Innocoll on the design of both new Phase 3 trials, and is currently conducting both studies within our CRO and site network:

Innocoll Biotherapeutics plc Announces First Patients In Phase 3 Clinical Trials for Label Expansion of Xaracoll® (bupivacaine hydrochloride) Implant

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Lotus Clinical Research 2019-2020 Highlights

Baudax Bio Non-Opioid Pain Drug Approval: In February, FDA granted approval to longtime Lotus client/ collaborator Baudax Bio’s non-opioid postsurgical pain therapy ANJESO. Lotus designed and performed both the Phase 2 and Phase 3 programs for this drug, with extensive scientific..

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