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AGA Says Guidance Will Catalyze Drug Development

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The American Gastroenterological Association praises FDA for its draft guidance on clinical evaluation of drugs for treating gastr...

ICH Guide on Elemental Impurities Released

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FDA releases an International Conference on Harmonization guidance on Q3D Elemental Impurities.

Patent Reform Threatens Innovation: Greenwood

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BIO president Jim Greenwood calls on Congress to change a patent dispute process that is hurting biotech companies.

FDA Sends Info on Clinical Trial Guidance to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance for...

Glucagon Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Glucagon for injection equivalent to 1 mg base/vial and equivalent 10 mg base/vial wa...

Guidance on Endocrine-Related Drug Toxicity

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Federal Register Notice: FDA releases a guidance: Nonclinical Evaluation of Endocrine-Related Drug Toxicity.

Despite Protests, FDA Hangs Tough on LASIK

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Despite continued agitation by patient activists claiming injuries from LASIK vision correction procedures, FDA says it has not fo...

Revised Guidance on Formal Dispute Resolution

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Federal Register Notice: FDA releases a revised draft guidance: Formal Dispute Resolution: Appeals Above the Division Level for CD...

Workshop on Human Genetic Variants Databases

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Federal Register Notice: FDA plans a public workshop 11/13: Use of Databases for Establishing the Clinical Relevance of Human Gene...

Workshop on NGS In Vitro Diagnostic Tests

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Federal Register Notice: FDA plans a public workshop 11/12: Standards-Based Approach to Analytical Performance Evaluation of Next ...