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The Strategic Value of Orange Book Data in Pharmaceutical Competitive Intelligence

Drug Patent Watch

Meet the Orange Book, a treasure trove of data that holds the secrets to pharmaceutical competitive intelligence. With its comprehensive list of approved drugs, patent information, and regulatory details, the Orange Book is an untapped goldmine of insights waiting to be mined.

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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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Leveraging Online FDA Information to Accelerate ANDA Timelines

thought leadership

Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.

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3 Ways to Ensure Your Marketing Fills Your Life Science BD Pipeline

Fierce BioTech

3 Ways to Ensure Your Marketing Fills Your Life Science BD Pipeline How can you keep your pipeline full of qualified leads when nobody seems interested in buying? The answer: a pipeline-supporting marketing plan that includes proven tools, well-executed tactics, and a clear strategy.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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[Podcast] What If MarTech Isn’t Just for Marketers? An Interview With HubSpot’s Scott Brinker

Perficient: Drug Development

, Jim talks with Scott Brinker , VP of Platform Ecosystems at HubSpot and editor of the pioneering blog chiefmartec.com , about the evolving world of marketing technology (MarTech) and how marketers can stay ahead. Marketers now juggle a mix of platforms, from CMS and email marketing to LinkedIn and Generative AI.

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Zigs & Zags – The Opposite of a Great Idea Can Also be a Great Idea

Perficient: Drug Development

Several books have been written on the concept, and many more refer to it when discussing differentiation and disruption within marketing and product development. It’s common that people view novel and innovative, first-to-market groups as having great ideas. Over the years the video game market has changed dramatically.

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