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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Drug Discovery

One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).

FDA
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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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The Real Cost of Complexity: What Every Drug Developer Needs to Know

PPD

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

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Scientific workflow for hypothesis testing in drug discovery: Part 1

Drug Target Review

Public datasets, linked papers or supplementary documents often provide essential context about the experimental setup. This document summarises the data analysis process, including the key findings, statistical analyses, and interpretations. The final step is the generation of a report.

RNA
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Pharmacognosy and Drug Patents: Unveiling Nature’s Medicinal Treasures

Drug Patent Watch

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.

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Universal Design for Visual Disabilities in Healthcare – Clear and Accessible Communication – 4

Perficient: Drug Development

Use Accessible Documents Large Print Materials: Provide printed materials in large print for patients with low vision. Braille Documents: Offer key documents in Braille for patients who are blind. Digital Text: Ensure that digital documents are accessible to screen readers.

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Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S.