+91 789 2456 581 | info@nckpharma.com

Please sign in first

Username

Password

Lost Your Password?

Not a member?

Please simply create an account before buying/booking any courses.

Create an account for free!

Home
- About Us
- Contact
NCK services
Course List
Admission
Corporate Training
Knowledge Base

Home
- About Us
- Contact
NCK services
Course List
Admission
Corporate Training
Knowledge Base

Pharma News

Keep updating your pharma knowledge

24 Sep 2017

What are the major differences between – Breakthrough Therapy Designation Vs. Fast Track Designation Vs. Priority Review Designation Vs. Accelerated Approval

/

Posted Byadmin

/

Comments0

/

TagsAccelerated Approval, Breakthrough Therapy designation, Fast Track designation, FDA grants Priority Review for potential new indication for Brilinta, priority review, Priority Review Designation, usfda accelerated approval

Here is a quick comparison of the USFDA drug development expedited programs. This may help you to distinguishing all of them effectively.

Related Articles

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
Turalio: USFDA approval of first therapy for rare joint tumor
Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma
BMS Opdivo+Yervoy combo received USFDA new indication approval.
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Quick look into Roche’s Tecentriq US FDA priority review grant

European approval for Roche’s tocilizumab for the treatment of giant cell arteritis (GCA)

USFDA approval of Verzenio to treat certain advanced/metastatic breast cancers

About Post Author

admin

Leave a Reply Cancel Reply

Search With Term

Recent Industry Update

Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
GSK grants exclusive technology license for Ebola vaccines to Sabin Vaccine Institute
Turalio: USFDA approval of first therapy for rare joint tumor
Case Study: The Mylan-Upjohn,Pfizer Merger
Take a Self Competency Test in European Drug Regulatory Affairs
Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals
Case Study : Rituxan – A Brand which Pharma Industry reckon
In which class should be register the food supplement?
Cipla’s JV with Jiangsu Acebright Pharma in China
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Case Study: Gilead and Galapagos – R&D collaboration
How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?
AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data
US FDA warning letter: Repackers distributing API for violations of cGMP violation requirements
Gilead introduces Asia Pacific Rainbow Grants program
Case Study: EC’s conditional marketing approval to Libtayo for advanced CSCC
What is Conditional marketing authorisation by European Medicine Agency?
List of USFDA approved Biosimilar [till date]
US FDA approves Pfizer’s Biosimilar Zirabev
What is USFDA Tentative Approval?
Case Analysis: Insight on AbbVie’s acquisition of Allergan
Glenmark’s licensing deal with Novartis to distribute three respiratory drugs in Brazil
What is CRL – Complete Response Letter by USFDA?
Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women
FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan
Case Study: Why Pfizer acquiring Array Biopharma?
Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant
USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
What is vertical integration?

Monthly Archieves

Certification Courses

View our online Certification Courses.

Related Articles

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
Turalio: USFDA approval of first therapy for rare joint tumor
Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma
BMS Opdivo+Yervoy combo received USFDA new indication approval.
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Quick look into Roche’s Tecentriq US FDA priority review grant

Corporate Training

View list of courses, simulation, e-books, libararies for Pharma Corporate, Government and Regulatory Bodies.

Related Articles

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
Turalio: USFDA approval of first therapy for rare joint tumor
Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma
BMS Opdivo+Yervoy combo received USFDA new indication approval.
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Quick look into Roche’s Tecentriq US FDA priority review grant

Subscribe to NCK Newsline

Enter your email address:

Delivered by FeedBurner

Popular 1 Year Courses

KPE – C- 024 KPE’s Executive Program in Pharmaceutical Global Business
KPE-C-001 KPE’s Advance Diploma in Pharmaceutical Product Management
KPE-C-003 KPE’s Advance Diploma in Drug Regulatory Affairs
KPE-C-004 KPE’s Advance Diploma in Pharma Marketing
KPE – C- 009 KPE’s Advance Diploma in Pharmacovigilance
KPE-C-005 KPE’s Advance Diploma in Pharmaceutical Production management
KPE-C-08 KPE’s Advance Diploma in Pharmaceutical Strategic Business Management

Javascript is disabled

Javascript is disabled on your browser. Please enable it in order to use this form.

Loading

Query

First Name

Last Name

Email Address

Your Query *

Write Here

3 plus 9 equals?*

Prove you are a human

Write here

Your form has been submitted

Thank you %NAME% for the submitting your query/feedback.

Server Side Error

We faced problems while connecting to the server or receiving data from the server. Please wait for a few seconds and try again.

If the problem persists, then check your internet connectivity. If all other sites open fine, then please contact the administrator of this website with the following information.

TextStatus: undefined
HTTP Error: undefined

Processing your request

Error

Some error has occured.

Disclaimer & Privacy Policy | Terms of Use

Copyright © 2014 - 2015 All Right Reserved - NCK Pharma Solution Private Limited

This website uses cookies to improve your learning experience. Ok Privacy Policy

Privacy & Cookies Policy

Necessary Always Enabled

Non-necessary

Scale up your Pharma knwledge to Next Level with our Free Content

Case studies & Caselets
Simulation based learning
Online self competency assessment tests

etc.