Newsletter | November 22, 2023

11.22.23 -- The 9 FDA Special Designations For Pipeline Drugs

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FEATURED ARTICLES

A Family Affair

For Krish and Suma Krishnan, the husband-and-wife leadership team at Krystal Biotech, bringing work home, and bringing home to work, is inevitable. A larger shared goal smooths the edges. 

An Overview Of The 9 FDA Special Designations For Pipeline Drugs

The FDA employs various special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and biologics license applications (BLAs), others may abbreviate the duration of clinical trials.

Pfizer To Provide Individual Participant Data At Scale

Pfizer has made a commitment to return individual data to its clinical trials participants through its Participant Data Return initiative.

NEW PODCAST EPISODE

Backpacks And Biotech With Luke Timmerman

Luke Timmerman's tireless advocacy stretches well beyond his professional coverage and punditry. Through his Timmerman Traverse initiative, he's figured out a way to weave his personal and professional passions into serving some of the philanthropic initiatives our industry cares about most. On the Business of Biotech, we'll get to know Luke personally, learn about his philanthropic work, and give listeners a healthy dose of optimism as we look ahead to the next decade in biotech.

INDUSTRY INSIGHTS

Involving The Patient In Clinical Trial Design

Learn how to create more patient-centered clinical trials, which can ultimately benefit both patients and the research community.

DIGITAL EDITION

November 2023 Digital Edition

Inside you will find more on:

  • AI & ML In Pharma
  • Bio Podcast Recap
  • REMS And The FDA
  • Patents In Peril

View the digital edition.

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