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Results: 1-10 of 137

FDA Guidance on Using Public Human Genetic Variant Databases for Genetic and Genomic-Based In Vitro Diagnostics
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 18 2018

On April 13, 2018, FDA issued final guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and


USP Will Not Revise Its Biologics Monograph Without Stakeholder Consensus
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 18 2018

On April 2, 2018, the United States Pharmacopeial Convention (“USP”) issued a statement that it will not develop a new monograph for a biologic unless


FDA Final Guidance on Liposome Drug Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 10 2018

On April 4, 2018, FDA issued final guidance on Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and


District court finds patent covering Cephalon’s wakefulness improving drug Nuvigil, valid in ANDA litigation
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 4 2018

The U.S. District Court for the District of Delaware ruled in favor of Finnegan clients Cephalon Inc., Cephalon France, and Teva Santé SAS, finding


FDA Draft Guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 30 2018

On March 23, 2018, FDA issued draft guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FDCA


FDA Final Guidance on DNA Reactive Impurities in Pharmaceuticals
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 26 2018

On March 14, 2018, FDA issued final guidance on M7(R1) Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in


FDA Draft Guidance on Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 9 2018

On February 16, 2018, FDA issued draft guidance describing the standardized format for electronic submission of data and information for all major (i


FDA Guidance on E18 Genomic Sampling and Management of Genomic Data
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 8 2018

On March 1, 2018, FDA issued nonbinding guidance on Genomic Sampling and Management of Genomic Data. The guidance was developed with the Expert


FDA Final Guidance on Scientific Evaluation of Beneficial Effects of Isolated or Synthetic Dietary Fiber
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 8 2018

On February 28, 2018, FDA issued final guidance on Food Labeling: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of


FDA Guidance on Standardization of Data and Documentation Practices for Product Tracing
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 8 2018

On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. FDA aims to provide