February 26, 2024
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
Lab Developed Tests
November 14, 2023
FDA Proposes Significant Changes to LDT Regulation
On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result...
October 5, 2021
Four Benefits of Requesting an FDA Pre-IND Meeting
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
July 12, 2021
Pedaling While Fixing a Flat: Conducting a Good FDA Meeting Under Bad Circumstances
Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...
November 1, 2018
FDA Encourages Development of Novel Drugs for Rare Diseases with Draft Guidance Regarding the Role of Pre-IND Meetings
On Monday, October 12th, FDA issued a draft guidance regarding the role of Pre-IND Meetings in the development of drugs to treat rare diseases. The document, entitled "Rare Diseases: Early Drug...
October 4, 2018
CBER Provides Sponsors with Policies & Procedures Regarding INTERACT Meetings
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
September 20, 2017
FDA Meetings: How to Prepare for FDA Type B Meetings
The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...
June 16, 2017
FDA to Host Public Workshop to Discuss the Impact of Abuse Deterrent Opioids
On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties. The workshop, entitled “Data and Methods for...
March 7, 2017
FDA to Hold Public Meeting to Discuss Patient-Focused Drug Development for Autism
On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism. In the notice published in the Federal Register, the FDA notes...