We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 154

FDA withdraws draft guidance for industry: statistical approaches to evaluate analytical similarity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On June 21, 2018, the Food and Drug Administration (FDA) withdrew its draft Guidance for Industry entitled “Statistical Approaches to Evaluate


FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products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On July 3, 2018, the FDA issued draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products.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


Requirements, Benefits, and Possible Consequences of Listing Patents in FDA’s Orange Book
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 3 2018

The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) amended patent law and drug law to facilitate


FDA Draft Guidance on Meetings Regarding the Development and Review of Biosimilar or Interchangeable Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • June 12 2018

On May 31, 2018, FDA issued draft guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Biosimilar User Fee Act (BsUFA) Products


FDA Proposed Rule on Product Jurisdiction
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • June 5 2018

On May 15, 2018, FDA issued a proposed rule amending its regulations in 21 CFR Part 3 on the classification of products as biological products


FDA Draft Guidance on Waivers, Exceptions, and Exemptions from FDA Act Section 582
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • May 29 2018

On May 9, 2018, FDA issued draft guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FDCA. Section 582


FDA Final Guidance on: Bioanalytical Method Validation
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • May 29 2018

On May 21, 2018, FDA issued final guidance on Bioanalytical Method Validation. The guidance incorporates public comments to the revised draft


FDA Draft Guidance on Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • May 22 2018

On May 9, 2018, FDA issued draft guidance on Uncomplicated Urinary Tract Infections (uUTIs): Developing Drugs for Treatment. The guidance addresses


FDA Draft Guidance on Pediatric HIV Infection: Drug Development for Treatment
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • May 22 2018

On March 14, 2018, FDA issued draft guidance on Pediatric HIV Infection: Drug Development for Treatment. The draft guidance provides general guidance


FDA Issues a Working Model for Software Precertification
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • May 8 2018

FDA recently issued an initial working model for its Software as a Medical Device (“SaMD”) Precertification Program. The model consists of four