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Home » Topics » Regulatory

Regulatory
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ARS shares dive on CRL for allergy spray Neffy

Sep. 20, 2023
By Karen Carey
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 55.8% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for Neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee (adcom) and following a three-month delay in action.
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Laptop displaying FDA logo

Med-tech harmonization plan is a study in regulatory incrementalism

Sep. 20, 2023
By Mark McCarty
The U.S. FDA is still sorting through the feedback for its proposal to modestly align the Quality System Regulation with ISO 13485, but the agency has posted a draft four-year plan for regulatory harmonization that is substantially broader in scope than just quality management system considerations. While this proposal addresses a significant need for device makers working in multiple markets, the objectives include an assessment of at least nine non-FDA harmonization proposals by the end of fiscal year 2025, a clear indicator that harmonization will continue to be every bit the slog it has proven to be in recent years.
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Regulatory actions for Sept. 20, 2023

Sep. 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Choicespine.
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Regulatory actions for Sept. 20, 2023

Sep. 20, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, AB Science, Astex, Atamyo, Beigene, Biophytis, Gilead, GSK, Intelgenx, Merck & Co., Otsuka, Pfizer, Rhythm, Viiv.
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Neuroderm pump

Patent update: Neuroderm improves the design for its wearable anti-Parkinson’s infusion pump

Sep. 20, 2023
By Simon Kerton
The latest patent application from Neuroderm Ltd. described a magnetic coupling and detection mechanism for its small two-part wearable infusion drug delivery device that delivers a liquid drug to Parkinson’s disease patients subcutaneously.
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Cytomegalovirus in a human cell
Infection

Spybiotech seeks clearance in UK to begin clinical testing of SPYVLP-01 for human CMV

Sep. 20, 2023
Spybiotech Ltd. has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP-01, a vaccine targeting human cytomegalovirus (CMV) using its hepatitis B virus-like-particle platform technology.
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Magnifying glass, FDA concept image

FDA converts conformity assessment pilot into a full-fledged program

Sep. 20, 2023
By Mark McCarty
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the agency has now converted the ASCA pilot into a full-blown regulatory program. Fortunately for both the FDA and industry, most of the guidance groundwork is already in place, making the ASCA program a ready-to-go method for streamlining at least one element of premarket applications for medical devices.
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Medici drug delivery system

Adcom a make-it-or-break-it hearing for combo diabetes product

Sep. 19, 2023
By Mari Serebrov
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
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FDA eyes overhaul of IT system with an emphasis on agency-wide integration

Sep. 19, 2023
By Mark McCarty
Developers of combination products face an unusual dilemma in their interactions with the U.S. FDA, given that the data for the constituent products reside in multiple product centers. Some of the related clunkiness may soon be a thing of the past thanks to a new four-year proposal to overhaul the FDA’s information technology infrastructure, which among other things will emphasize a more seamless sharing of data across centers, precisely the kind of initiative that would facilitate reviews of combination products.
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Regulatory actions for Sept. 19, 2023

Sep. 19, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airamed, Inbrain Neuroelectronics, Natural Cycles, Spectrawave, T2 Biosystems, Tasso.
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