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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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Avacta Announces Collaboration Agreement With Bruker

The Pharma Data

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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Best OINTMENT or CREAM for insect bites

Druggist

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). For many customers, ointment or cream for insect bites is the first line of rescue in stings management. What causes bite itchiness and redness? Hydrocortisone cream for insect bites.

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FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation

Camargo

Per the FDA’s guidance on RPDD : In vitro data supporting the mechanism of action of the drug in the disease or in a related disease may suffice for rare pediatric disease designation, whereas that level of data would not generally suffice for orphan-drug designation. Criteria for Rare Pediatric Disease Designation.

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XPhyto Announces RT-PCR Test for Point-of-Care COVID-19 Detection

The Pharma Data

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

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Progenity, Inc. Prices $75.0 Million Convertible Senior Notes Offering – Dec 03, 2020

The Pharma Data

The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. (NASDAQ: PROG) today announced the pricing of its offering of $75.0 million principal amount of notes. The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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Progenity Announces Pricing of Public Offering of Common Stock – Dec 03, 2020

The Pharma Data

The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. SAN DIEGO, Dec.