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Results:1-10 of 153

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections
  • Duane Morris LLP
  • USA
  • November 9 2018

The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the


Redraft of 510(k) Third Party Review Program
  • Duane Morris LLP
  • USA
  • November 8 2018

Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes


FDA Unveils New Quality in 510(k) "Quik" Review Program Pilot
  • Duane Morris LLP
  • USA
  • October 22 2018

The 510(k) process provides a review procedure for marketing clearance of devices that are "substantially equivalent" to other approved devices or to


FDA Estimates for Formal Meetings Regarding Development of Biosimilars Show Continued Growth of Biosimilars in the United States
  • Duane Morris LLP
  • USA
  • October 2 2018

FDA's upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. Among the key aspects in


FDA Releases Revised Draft Memorandum of Understanding for Human Drug Compounding
  • Duane Morris LLP
  • USA
  • October 1 2018

The U.S. Food and Drug Administration recently announced the release of a revised Draft Memorandum of Understanding (MOU), Addressing Certain


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