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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

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Prosecutors: Convicted CEO Elizabeth Holmes is a flight risk

STAT

(AP) — Elizabeth Holmes is a flight risk and shouldn’t be allowed to stay out of prison while she appeals her 11-year prison sentence for defrauding investors, federal prosecutors said in court documents. Holmes had a one-way plane ticket to Mexico booked for Jan.

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Episode 908: Finally, All the VTE Recommendations In One Document!

Pharmacy Joe

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

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Typical GMP documentation in a quality control laboratory

GMPSOP

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

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Episode 908: Finally, All the VTE Recommendations In One Document!

Pharmacy Joe

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document. appeared first on Pharmacy Joe.

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How I Educate Series: Whitney Johnson, MD

ALiEM - Pharm Pearls

We are all working to improve daily and avoid cook book medicine, anchoring bias, and premature closure that can contribute to healthcare disparities. Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet.

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Drug Channels Recommends: “Uncontrolled Spread” by Scott Gottlieb

Drug Channels

This book provides a comprehensive, well-written chronicle of the COVID-19 pandemic (as of mid-2021). Dr. Gottlieb documents—with great specificity—how and why our government’s public health infrastructure failed us during the pandemic. Amazon link). He also offers valuable recommendations for better planning. to 1:30 p.m.