Regulatory Sciences
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
FDA Encourages Development of Novel Drugs for Rare Diseases with Draft Guidance Regarding the Role of Pre-IND Meetings
On Monday, October 12th, FDA issued a draft guidance regarding the role of Pre-IND Meetings in the development of drugs to treat rare diseases.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...
Regulatory Sciences
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...
Clinical Research Solutions
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)...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
#8: Special Protocol Assessment
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...