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Results: 1-10 of 183

FDA Proposes to Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes
  • Duane Morris LLP
  • USA
  • June 12 2018

The Food and Drug Administration (FDA) classifies drug products as a biological product, device, drug or combination product, and assigns the product


FDA to Consider Approval of Botanical (not synthetic) CBD Drug
  • Duane Morris LLP
  • USA
  • April 17 2018

On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW


FDA Accepting Comments on CBD for UN Commission Meeting
  • Duane Morris LLP
  • USA
  • January 26 2018

The Food and Drug Administration (FDA) is accepting comments to help formulate the United States' position on the World Health Organization's


FDA Announces Ambitious Agenda in 2018 Compounding Policy Priorities Plan
  • Duane Morris LLP
  • USA
  • January 23 2018

Achieving balance between promoting patient access to medications and implementing measures designed to ensure medications are safe has been a recurrent theme from the U.S. Food and Drug Administration


Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
  • Duane Morris LLP
  • USA
  • November 21 2017

The goals of GDUFA II, among others, are to "clarify regulatory expectations for prospective applicants early in product development, assist


FDA Warns Cannabidiol-Infused Products Manufacturers Over Health Claims
  • Duane Morris LLP
  • USA
  • November 14 2017

The FDA has recently issued warning letters to four companies concerning the marketing of products containing cannabidiol, alleging that claims made


FDA Outlines Its Operation for Facility Evaluation
  • Duane Morris LLP
  • USA
  • September 14 2017

The FDA conducts pre-approval facility evaluations and inspections to ensure conformation with Current Good Manufacturing Practice (CGMP) requirements


FDA Increases Priority Review Opportunities for Drug Products with Limited Competition
  • Duane Morris LLP
  • USA
  • July 18 2017

The FDA hopes to increase market competition for prescription drugs and facilitate entry of lower-cost alternatives. Following the Drug Competition


FDA Issues Draft Guidance on Pre-Submission Facility Correspondence - A Way to Reduce FDA Action Times for Priority ANDAs
  • Duane Morris LLP
  • USA
  • July 14 2017

FDA has set a goal to review and act on priority ANDAs two months faster if the submission meets all PFC requirements. The U.S. Food and Drug


FDA Issues Final Guidance on Quality Agreements in Arrangements for Contract Manufacturing of Drugs
  • Duane Morris LLP
  • USA
  • January 3 2017

The U.S. Food and Drug Administration (FDA) has released a final guidance, entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements