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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 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


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 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FDA Issues Draft Guidance on Pre-Submission Facility Correspondence - A Way to Reduce FDA Action Times for Priority ANDAs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


FDA Issues Final Hatch-Waxman Regulations
  • Duane Morris LLP
  • USA
  • October 7 2016

The U.S. Food and Drug Administration (FDA) on October 6, 2016, finally issued a Final Rule to implement provisions of the Medicare Prescription Drug