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Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). & Mfrs.

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How to Get Ozempic & GLP-1’s Covered by Insurance (or Save Big with Plum Health Direct Primary Care): The Ultimate Guide You Can’t Afford to Miss!

Plum Health

Managing diabetes—especially as you get older—can be challenging physically, emotionally, and financially. Everything You Need to Know About Costs and Coverage Patient is inquiring about healthcare. GoodRx can help you navigate between copay savings cards and patient assistance programs to save money on your prescription.

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Fun With Primescan and Atlantis

CDOCS

& Patient presents as an 80 year old woman who was wearing an ill fitting partial for awhile and was losing weight because eating was very difficult. & jpg]</p> <p>So, once the bridge came in from the lab, we had the patient come in. & jpg][image:Untitled_2_012.jpg]</p> jpg][image:Untitled_2_012.jpg]</p>

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

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. is it the lab itself, the healthcare provider, or the patient?).

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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

FDA Law Blog

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(d)