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Browse articles with tag: Regulatory Guidelines
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Knobbe Martens
Feb 2, 2018
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Featured
FDA Pre-cert Program for Lab-Developed Tests
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the...
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Knobbe Martens
Feb 2, 2018
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FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all...
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Valerie Clark
Feb 16, 2012
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FDA offers new guidance for evaluating generic biological products
Biological pharmaceuticals are therapeutic drugs made from human or animal materials rather than chemicals, often indicated for immune system-related deficiencies....
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Mikele Bicolli
Apr 19, 2024
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Patent Prosecution
USPTO Proposes Patent Fee Adjustments for FY 2025
The United States Patent and Trademark Office (USPTO) is proposing adjustments to patent fees for fiscal year 2025. These changes,...
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