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
|
30 April 2012
EMA Releases Paper on Advanced Therapies to Assist Sponsors
0 Likes
The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)—therapies made from genes and cells—which aims to clarify the
Read More...
Tags:
Advanced Therapy Medicinal Products
Assistance
ATMP
Clarification
Classification
EMA
Guidance
Reflection Paper
Submissions
Voluntary
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
Regulatory Intelligence Firm Graematter Gets Major Funding to Navigate Complex FDA Environment
22 May 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
Most Viewed
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
Warning Letter to Company Cites Low Supplies of Toilet Paper
15 May 2013
