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#ScienceSaturday: October 21, 2023

KIF1A

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

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The first major set of genetic associations found in long COVID

Drug Target Review

The study mentions the overlap in genes associated with Fatigue Dominant long COVID and ME/CFS, including those involved in circadian rhythm regulation and insulin regulation. How do these genetic similarities provide insights into the commonalities between these conditions and their biological mechanisms?

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

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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 ). Gaulkin & Jeffrey N.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). Complaint ¶ 62. Complaint ¶ 63.

Pharmacy 139
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Therapies 119
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Coronavirus antibodies tests 'put public at risk'

The Pharma Data

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

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Compliant Science: The Critical Role of Compliance for Medical Affairs

H1 Blog

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.