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Results:1-10 of 147

Four Ways to Show Nonobviousness of ADC Inventions
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 5 2018

When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000,1 only a handful of patent


FDA Draft Guidance on Postapproval Changes to Drug Substances
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • September 25 2018

On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug


FDA Draft Guidance on Indications and Usage Labeling
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 31 2018

On July 6, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist applicants in writing the Indications and Usage section


SaMD Series: The Interplay Between IP and FDA Submissions
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 30 2018

Software as a Medical Device - also referred to as SaMD - is one of the fastest growing innovations in the medical device industry. As with any


FDA Final Guidance on Labeling for Biosimilar Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 23 2018

On July 18, 2018, the FDA issued final guidance on “Labeling for Biosimilar Products.” The guidance provides recommendations for drafting prescribing


FDA Guidance on ANDA Submissions Amendments to Abbreviated New Drug Applications Under GDUFA
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 19 2018

On July 5, 2018, FDA issued nonbinding guidance on ANDA Submissions Amendments to Abbreviated New Drug Applications Under GDUFA. The guidance


FDA Draft Guidance on Nonclinical Studies and Labeling for Oncology Therapeutic Radiopharmaceuticals
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 19 2018

On May 31, 2018, FDA issued draft guidance on nonclinical studies and labeling recommendations for products containing a radioactive compound (i.e., a


Statistical Approaches to Evaluate Analytical Similarity
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 18 2018

米国食品医薬品局FDAは2018年6月21日昨年9月に発行されていた分析的類似性に用いる統計的アプローチと題する企業向けドラフトガイダンスを取りやめた本ガイダンスではバイオシミラー申請人がバイオシミラーと参照製品の分析的類似性を確立するための手法が提示されていた今回の取りやめ理由としてFDAはパブリックコメントに寄せられたバイオシミラー開発の費用及び効率性に潜在的に影響を与えるであろう様々な問題を熟慮した結果関連する科学的及び規制的課題の更なる考察を行うためとしている FDAは将来的にはドラフトガイダンスを発行する意向を示しておりその指針については以下のように述べている分析データを評価する最先端科学技術を反映したものであり且つ参照製品中の潜在的ロット間の可変性を考慮しつつ分析データを適正に評価する方法を提示し市場参入を目的としたバイオシミラー申請書を評価するFDAの厳格な科学的基準に妥協することなく効率的な開発を後押しできるようバイオシミラー申請人に柔軟性を与える内容とする 詳細はこちらのFDA取りやめ決定の本文をご覧ください


FDA withdraws draft guidance for industry: statistical approaches to evaluate analytical similarity
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 18 2018

On June 21, 2018, the Food and Drug Administration (FDA) withdrew its draft Guidance for Industry entitled “Statistical Approaches to Evaluate


FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 17 2018

On July 3, 2018, the FDA issued draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products. The