RAPS.org
|
About RAPS
|
RAPS Store
|
Contact
Guest
| limited access
log in
Join RAPS
Get the Mobile App
|
RF in Your Email
News
Features
Archives
About RF
Advertise
Regulatory Exchange
Departments:
Under RAPS
Quality & Compliance
Science & Technology
Perspective
It's the Law
Focus Online
»
News
News
Search:
Latest News
|
2 August 2012
Revised FDA Manual Provides Statistical Reviewers with Standardized Template
0 Likes
A revised Manual of Policies and Procedures (MAPP) developed for US Food and Drug Administration (FDA) drug review staff instructs them on how to assess statistical reviews using good review practices
Read More...
Tags:
CDER
FDA
MAPP
OTS
Revised
Statistical Review
Template
Get
RF Today
RF Today
is
Regulatory Focus'
daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more.
Learn more
Sign Up
Most Viewed
Most Popular
Most Popular
Five in Focus | Regulatory Changes Await Global Device Industry, FDA Makes a Major Announcement
19 April 2013
Interview: FDA's UDI Architect Jay Crowley on the Agency's Approach to UDI and Pending Changes
2 May 2013
Citing Personal Reasons, Major Official Announces Departure from FDA
3 May 2013
Patients First: FDA's New Website Aims to Make Regulations Clear to Everyone, Invite Involvement
23 April 2013
Senate Track and Trace Legislative Draft Includes Lot-Level Requirements and New Penalties
22 April 2013
Regulatory Reconnaissance (22 April 2013)
22 April 2013
Regulatory Reconnaissance (25 April 2013)
25 April 2013
IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA
29 April 2013
Most Viewed
China's SFDA Becomes CFDA amidst Consolidation of Power and New Leadership
25 March 2013
FDA Plans Huge Cardiovascular Registry With Focus on Medical Devices
2 April 2013
In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices
15 April 2013
Goodbye, KFDA: Korean Regulator Gets New Name, Decentralized Authority After Reorganization
28 March 2013
FDA Gets Go-Ahead for Study of DTC Advertising and Social Media
18 April 2013
UPDATED: President's Budget Proposal Calls for Small Increases at FDA, but Big Changes for Industry
11 April 2013
IBM Awarded Huge Contract to Modernize Regulatory Review Processes at FDA
29 April 2013
New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars
30 April 2013
