PharScite

PharScite

Pharmaceutical Technology

  • Home
  • Services
  • Courses
  • Events
  • Blog
  • News
  • Contact

Guidance Documents

Home Food and Drug Administration Guidance Documents
FDA Guidances

Draft Guidance for Preparing a Pre-Request for Designation

By Sharif AhmedCombination Product
On February 15, FDA issued a draft guidance on How to Prepare a Pre-Request for Designation (Pre-RFD). This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the Pre-RFD process. Specifically, this guidance explains the Pre-RFD process at the Office of Combination Products (OCP)…

Guidance May Not be Used as a Substitute for Rule making

By Sharif AhmedDepartment of Justice
On November 2017, Trump Administration issued a memo stating that “the Administrative Procedure Act requires notice-and-comment rulemaking when purporting to create rights or obligations binding on members of the public or the agency.”  In the memo the Department of Justice stated that “The Department will no longer engage in this…
FDA Guidances

New Draft Guidances on Medical Product Communications

By Sharif AhmedFood and Drug Administration
Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products. The first draft guidance, “Drug and Device Manufacturer Communications with…
1 Blue Hill Plaza, Suite 1509
Pearl River, New York 10965

Phone: +1 845-675-8540
Fax: +1 845-203-1495
Professional Development
Information Technology Solutions
Regulatory Services
Regulatory Insight
Regulatory Updates
Popular Courses
Upcoming Events

Subscribe to our RegLog and receive latest blog posts.
  • facebook
  • twitter
  • linkedin-square
  • instagram
  • youtube-play
Copyright © 2019 PharScite, LLC. All Right Reserved.
  • Terms
  • Privacy
  • Policy
  • Careers
✕
  • Home
  • Services
  • Courses
  • Events
  • Blog
  • News
  • Contact