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STAT+: FDA and large compound pharmacies settle a long-running dispute over a key list for ingredients

STAT

Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…

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Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

STAT

Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations. Read the rest…

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

The FDA Law Blog

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Richardson & Karla L. See 21 U.S.C. 353b(a)(8). Section II at 2.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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9 foods high in estrogen

The Checkup by Singlecare

Foods high in estrogen Phytoestrogens are estrogen-like plant-based compounds and are the form of dietary estrogen obtained from foods we consume. Food and Drug Administration (FDA). Functions and action mechanisms of flavonoids genistein and icariin in regulating bone remodeling , Journal of Cellular Physiology (2013).

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2013; 102(1): 52–61. Cited 2023Feb].

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NITROSAMINES: Where now?

European Pharmaceutical Review

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. 2022; 35(11): 1997–2013. J Pharm Sci.

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