FDA News & Notes – Week of Aug. 8, 2016
Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of Aug. 1, 2016. Times listed are local time.
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Meetings, Workshops and Congressional Testimony:
Wednesday, 8/10 –
The Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
will meet to discuss, make recommendations and vote on information regarding a de novo request for the Seeker Newborn Screening System (Seeker System), by Baebies, Inc. The Seeker System consists of the Seeker Analyzer, the Seeker 4-Plex Assay Kit, the Seeker Cartridges, the Spot Logic software, and quality control materials; it uses digital microfluidic technology to measure multiple lysosomal enzymatic activities quantitatively from newborn dried blood spot specimen. The meeting will take place beginning at 8 a.m. at the Hilton Hotel, Gaithersburg, Md.
In Case You Missed It:
– News Release: Kratom seized in California by US Marshals Service
. The FDA announced that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.
– FDA Voice Blog: Piloting an Improved Intercenter Consult Process
. Combination products—those that combine drugs, devices, and/or biological products—present both policy and review challenges in large part because they include constituent parts that fall into more than one regulatory category (e.g., drug and device; drug and biologic) covered by more than one FDA product center. As such, close intercenter collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review.
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