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Good Review Management Principles & Practices, Part One: Fundamental Values

thought leadership

On Tuesday, September 25 th , the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics license applications (BLAs), or efficacy supplements/supplements with clinical data.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations. A well-documented case is Sarepta Therapeutics’ eteplirsen , a drug developed for Duchenne muscular dystrophy.

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ChEBI 2.0 Data Products

The ChEMBL-og

If you want to read the documentation about the tables and columns in the database, you can visit our new ChEBI Database documentation website. Old ChEBI ChEBI 2.0 We have fixed that in the redevelopment. Old ChEBI didn’t have proper XML data types for annotation properties, so all of them were processed as strings.

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Optimizing Your Drug Patent Strategy: A Comprehensive Guide for Pharmaceutical Companies

Drug Patent Watch

Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.

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2025 Gynecology Licensing Trends Report: 150+ Deals by Company, Therapy & Tech

The Pharma Data

Comprehensive Report Reveals Key Trends in Gynecology Collaboration and Licensing Deals from 2016 to 2025 Gynecology Collaboration and Licensing Deals report offers a deep dive into the evolving landscape of partnerships in women’s health, providing unparalleled insights into over 150 strategic deals executed globally between 2016 and 2025.

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Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average

Drug Patent Watch

Unported License. The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch - Make Better Decisions. link] Drug developers require access to scientific information in….

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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.