STAT

SEPTEMBER 10, 2023

Among people who are still paying attention to Covid-19 , there’s been a recent surge — not just in viral activity but in the concern once again being paid to Covid. Headlines announce that transmission is surging and hospitalizations for Covid are rising by alarming percentages. There’s debate in some places about whether or not to resume wearing masks.

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Hospitals 145

The FDA Law Blog

SEPTEMBER 10, 2023

By Mark A. Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program. This finalized a draft guidance issued in December 2021, largely similar in substance.

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FDA Documentation Vaccines 108

STAT

SEPTEMBER 10, 2023

SAN DIEGO — Crinetics Pharmaceuticals announced on Sunday that its experimental drug for acromegaly, a rare and serious hormonal disorder, succeeded in a late-stage trial, bringing the San Diego biotech a step closer to applying for Food and Drug Administration approval — and entry into a crowded market with blockbuster therapies sold by pharma giants.

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FDA 130

ISPE

SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. Watson, PhD Melinda Imperati S. Connor Dennis, PhD Roger Nosal 1 September 2023 As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple count

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Documentation Process Improvement Packaging Pharmaceutical Companies 98

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Med Ed 101

SEPTEMBER 10, 2023

The Enjoyable Way To Study For The PTCB Exam! Introducing our new PTCB Crossword Puzzle Book! Great gift for any pharmacy technician or aspiring pharmacy student! We are excited to release a brand new book for our pharmacy technician friends! This will be priced as cheap as Amazon will let me for a short period […] The post As Cheap As Amazon Will Let Me!

PTCB 52

PTCB 52

BioPharm

SEPTEMBER 10, 2023

The biopharmaceutical industry supply chain experiences many bottlenecks, some of which may impact the sourcing of biochemicals and raw materials necessary to fulfill manufacturing demands during late stages of drug development. Establishing a partnership with a raw materials supplier with expertise in sourcing can be beneficial in navigating any unexpected turbulence and mitigating more common issues.

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