Home > By category > Mobile >Books > IND/NDA Booklet



IND/NDA Booklet

  • Downloads: 
  • Views: 
  • Rating:

In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The Investigational New Drug (IND) and New Drug Application (NDA) applications are the vehicles through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the US. 21 CFR Part 312 and 314 contain regulations applied to conducting clinical trials, working with FDA, applying for drug approval and other related topics.

The IND/NDA booklet App presents the regulations for IND and NDA in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.

Keywords : Investigational New Drug, IND, New Drug Application, NDA, drug approval, FDA, Regulation, Regulatory

Free download from Shareware Connection - In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The Investigational New Drug (IND) and New Drug Application (NDA) applications are the ...

Publisher: Quality and Invention | License: Shareware | Price: 1.99
Version: 2.0 | Size: 429 KB | Platform: Android 2.x,Android 3.x,Android 4.4,Android 4.x
Released Date: 03-09-2014 | Rating: 0 | Title: IND/NDA Booklet

Author Url: http://www.qualityinvention.com
Program Info Url: http://www.qualityinvention.com
Download Url: http://www.qualityinvention.com

More downloads from IND/NDA Booklet publisher Quality and Invention:

GLP Booklet - The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, FDA ...

Molar Calculator - Molar Calculator is a user-friendly, simple, versatile App for calculating molecular weight and more. It contains a molecular weight calculator preset with the precise weights of 90 elements, including commonly used metallic elements in chemistry,...

PMA/510k Booklet - Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PMA is an application submitted for approval to market. PMA approval is to be based on a ...

EU-GMP Chapter - Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their ...

EU-GMP Guide - Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their ...

IND/NDA Booklet related downloads:

AxpertSoft Pdf Booklet Creator - AxpertSoft Pdf Booklet Creator is a handy and reliable application designed to join multiple PDF documents into a complex booklet ready for printing.

Pdf-Booklet - Pdf-Booklet is a small, easy to use application based on the Python programming language, specially designed to help you make booklets from existing PDF files.

PDF Booklet Creator - PDF Booklet Creator is a small, easy to use application specially designed to help you create a booklet PDF from a ordinary PDF , for you to print, fold and fix in the back.

Orientation and Mobility Family Booklet - Orientation and Mobility Family Booklet helps you create an orientation and mobility booklet for the families of your students with eye problems.

Make Pdf Booklet - Acrobat PDF to Booklet PDF Maker software quickly converts your normal pdf documents into booklet format which can later be printed on papers. Tool easily creates booklet layout of multiple pdf documents by combining them all together.

Shareware Connection periodically updates pricing and software information of 'IND/NDA Booklet' from company source 'Quality and Invention' , so some information may be slightly out-of-date. You should confirm all information before relying on it. Software piracy is theft,  Using 'IND/NDA Booklet' crack, password, serial numbers, registration codes, key generators is illegal and prevent future development of IND/NDA Booklet.

New Reviews

SnapCrab - Nearly every PC users need to take screenshots from time to time, whether it is for personal or professional needs. While using the basic Windows screenshot capture method is available, it is not adequate for everyone. When you want to capture ...

Driver Fusion - To keep your laptop and desktop running smoothly and get the best performance out of it, it is important to pay attention to some aspects. It is quite important to ensure your PC device drivers are updated. Components like motherboards, GPU and ...

MagiX Video Pro - For PC users, there is no shortage of software to edit video. However, not all video editors come with the required features and versatility to edit complex projects and deal with several gigabytes of HD content easily. The high end video editors ...

Sony Movie Studio 13 Platinum - Sony enjoys a prime position in consumer level media software development and its Movie Studio has a large fan following. However, in recent years competition from Adobe and Corel has caught up. The recent overhaul of Sony’s video editor ...

CCleaner Network Edition - Keeping computers clean of redundant and junk data is a prerequisite and these are various methods to do that. Apart from integrated utilities that come with Windows, you can also use third party utilities to keep PC clean of junk files and ...

Soft4Boost Slideshow Studio - Nowadays you can record video using a number of devices including smart phones and tablets. However, some people still prefer using still images and music to create slideshows. Slideshows can be created for preserving fond memories digitally with ...

Cryper - Nowadays PC users can no longer rely completely on any security software. Newer ways of data theft and exploits are emerging on the horizon, making PC security a complicated and worrisome thing. If you are particular about the data you store in ...

CleanMyDrive - PC experts unanimously agree that using Macs tend to be a smoother and faster experience than running Windows based PCs but the Apple laptops and desktops also need maintenance and performance tweaking, occasionally. Regular web browsing, ...

Norton Zone - With a lot of your data being stored in some cloud service or other, it becomes necessary after a point to zero in on any one service rather than using many at the same time. As it is, major software companies are resorting to cloud based service ...

Adobe Media Encoder - Almost every PC user faces a situation where he or she needs to convert an audio or video file fast into a format of choice. There are several free and commercial apps, but the abundance of options can actually make selection difficult. If you ...




New Downloads

Edraw MindMaster

MindMaster is a cross-platform
and multi-functional mind
mapping software. It provides
effective mind mapping
solutions ...

Trianon Borgo Pio srl

Best Apartments to rent in the
heart of Rome and News

JFK PeopleTracker

Peopletracker is used to track
devices.Features:Can capture
latitude and longitude through
A-GPSCan capture latitude and
...

Illinois Constitution

Constitution of the State of
IllinoisLast update
2011-08-10Features:- Automatic
and free updates to changes-
Data is ...

Moving On Quote Wallpapers

Whether it's a hard break up,
the loss of a loved one, or
simply a big life change,
moving on is tough and
sometimes we ...

Desert Valley HD lite

Animated landscape of the
torrid desert
valleyInstructionHome -> Menu
-> Wallpapers -> Live
WallpapersBest for ...

Generic Map UI

This is an application for
prototyping M2M application
that use location data.The
application connects to an
MQTT broker ...

American Political Science
Rev

American Political Science
Review is political science's
premier scholarly research
journal, providing
peer-reviewed ...

Franklin PTC

The Franklin PTC App connects
parents with the PTC and
Franklin School overall.
Install this app to know what
is going on ...

Tiny Tractor Tales (Free)

Spaß mit dem Traktor.Fahr
einen Traktor! Verwende die
verschiedenen Hänger um Gras
zu mähen, das Gras zu
Heuballen zu ...

Avalon Park

The Avalon Park app was the
first community based app and
was featured on Fox News and
in the Orlando Sentinel.This
app ...

SuiVie Chien

L'insuffisance cardiaque est
responsable d'une augmentation
de la fréquence respiratoire
de votre chien. Si votre chien
...