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Blogging

RX Note

Introduction During my teenage years, blogging was a popular thing. At that time, I had a dream to compile my life into blog posts , which I will review when I am old. Is Blogging Dead? In 2020, there are more than 500 million blogs out of 1.7 WordPress offers an option to buy a hosting plan and domain name.

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Guest Blog: Wrapping Up Heart Month: A Message from WomenHeart

Putting Patients First Blog

Guest Blog: Wrapping Up Heart Month: A Message from WomenHeart February 26, 2024 By: Lori Ann Wood, WomenHeart Champion, WomenHeart WomenHeart is the first and only national, patient-centered organization dedicated to serving women with heart disease, and “WomenHeart Champions” are the boots on the ground in this fight against heart disease.

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Guest Blog: Raising Awareness, Sharing Knowledge: Celebrating World Bronchiectasis Day July 1st

Putting Patients First Blog

Guest Blog: Raising Awareness, Sharing Knowledge: Celebrating World Bronchiectasis Day July 1st June 26, 2023 By: Christina Hunt, BS, RRT , Director of Bronchiectasis and NTM Research and Education for the COPD Foundation. Epub 2015 Mar 18.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law Blog: Biosimilars

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. See our prior blog post on the topic here. The plan should identify the methods for verifying and validating the change.

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FDA’s Summer Plans May Include LDT Rulemaking

FDA Law Blog: Biosimilars

The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan. The announcement in the Unified Agenda of a planned NPRM is the most concrete evidence that FDA is moving forward with this plan. Javitt & McKenzie E.

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An Action Plan for Procurement To Unleash AI’s Power

Pharma and Life Sciences Blog

An Action Plan for Procurement To Unleash AI’s Power annmarie@AZglo… Tue, 04/23/2024 - 22:51 Generative AI goes above and beyond previous tools. It’s capable of generating entirely new content. How can procurement capitalize on this revolution?

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog: Biosimilars

The purpose of a predetermined change control plan (PCCP) is to avoid the need for such post-market assessments – and the delay and expense entailed when it is determined that a new submission is needed – through prospectively defining a process for making post-market changes. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)