Welcome to
On Feet Nation
GRAHAM MULFY Online
First, PDG will help you determine if an IND is required. FDA Guidance notes that there are times when it may not be clear if use of an FDA-regulated product might trigger an IND filing. However, FDA does not charge sponsors for Pre-IND meetings. PDG has orchestrated early stage strategies and Pre-IND Meetings for a variety of submissions including new clinical uses of a marketed drugs (new indications), new formulations and fixed dose combination products. Moreover, PDG has had success in using existing data from both clinical and animal models to support utility in new indications.
IND Consulting
Should the IND be required, PDG will help you every step of the way in compiling, submitting and amending your IND as well as preparing IND Annual Reports. PDG will investigate and summarize available safety information to support reasonable safety for study in humans, prepare the protocols and Investigator Brochures, and help you address and prepare for manufacturing issues including DMF Letters of Authorization, stability and GMP issues.
Special Protocol Assessment
Of utmost importance, PDG has extensive experience in gaining FDA agreement for consideration of Special Protocol Assessment (SPA) of trials forming the primary basis of efficacy claims in NDAs. The SPA is an agreement between the FDA and the sponsor that addresses design and analysis issues before the study begins. FDA actually signs an agreement that if the study is conducted as specified in the SPA and the endpoints are met, the drug will be approved. Experience has taught PDG that a SPA is reassuring to investors that endpoints are appropriate for approval and that the sponsor is in serious dialogue with FDA in its development efforts.
One of PDG’s primary goals (and successes) in Pre-IND Meetings and through the compilation and submission of the IND is to provide FDA with developmental context as well as assurance that they will receive a complete and timely protocol for SPA consideration.
Source: https://pharmdevgroup.com/investigational-new-drug-application-inds...
Also Visit:
https://about.me/pharmaceuticaldevelopmentservi
https://www.skillshare.com/user/pharmaceuticaldevelopmentgroup
https://500px.com/p/pharmaceuticaldevelopmentgroup?view=groups
https://www.scribd.com/user/458643251/pharmaceutical-development-se...
https://www.goodreads.com/user/show/96871318-pharmaceutical-consulting
https://en.gravatar.com/pharmaceuticaldevelopmentgroup
https://www.feedsfloor.com/profile/pharmaceutical-development-group
https://www.wysp.ws/pharmdevgroup/
https://www.beverlyreview.net/users/profile/pharmdevgroup/about/
https://www.dermandar.com/user.php?q=pharmdevgroup/
https://fairygodboss.com/users/profile/FRDsTElcgg/pharm-development...
https://www.bitsdujour.com/profiles/Idk87t
https://www.bibrave.com/users/143492#.YLxQH_kzZPY
https://www.blurb.com/user/pahrmdevgrou?profile_preview=true
https://orcid.org/0000-0003-2782-5101
https://letterboxd.com/pahrmdevgroup/
https://www.free-ebooks.net/profile/1309408/pharm-development-group
https://audiomack.com/pahrmdevgroup
https://articlesjust4you.com/members/pahrmdevgroup/
https://www.crunchyroll.com/user/pahrmdevgroup
https://news.wirefly.com/authors/pharm-developmentgroup
https://www.brijj.com/pharm-development-group?route=head
https://www.kickstarter.com/profile/613677000/about
https://www.instructables.com/member/pahrmdevgroup/?publicPreview=true
https://speakerdeck.com/pahrmdevgroup
https://dreevoo.com/profile.php?pid=231875
https://www.lyla.ch/profile/239476-pahrmdevgroup/
https://truxgo.net/profile/58699
http://www.mathisfunforum.com/profile.php?id=236957
https://www.flickr.com/people/193236996@N08/
https://www.twitch.tv/pahrmdevgroup/about
https://www.goodreads.com/user/show/136071281-pharm-development
https://vimeo.com/pahrmdevgroup
https://www.bakespace.com/members/profile/pahrmdevgroup/1216248/
http://hawkee.com/profile/782069/
https://artmight.com/user/profile/177079
http://www.effecthub.com/user/1933820
https://esplor.io/pahrmdevgroup
https://trello.com/pharmdevelopmentgroup
https://imgpile.com/pahrmdevgroup
https://www.playping.com/pahrmdevgroup
https://actionnetwork.org/users/pharm-development-group/profile
https://bibliocrunch.com/profile/pahrmdevgroup/
https://pinshape.com/users/1591317-pahrmdevgroup#designs-tab-open
http://www.digthedirt.com/users/1222511-pahrmdevgroup
https://git.qt.io/pahrmdevgroup
https://www.bonanza.com/users/49190956/profile?preview=true
https://withoutyourhead.com/profile.php?autoid=107937
https://radiovybe.com/pahrmdevgroup
https://forums.socialpointgames.com/user/pahrmdevgroup
https://ebusinesspages.com/pahrmdevgroup.user
https://www.demilked.com/author/pahrmdevgroup/
https://www.webtoolhub.com/profile.aspx?user=42264878
http://www.cruzroja.es/creforumvolint_en/user/editDone/160050.page
https://godotengine.org/qa/user/pahrmdevgroup
http://forum.dawahfrontnigeria.com/member.php?action=profile&ui...
© 2024 Created by PH the vintage. Powered by
You need to be a member of On Feet Nation to add comments!
Join On Feet Nation