Subscribe

Recent Articles

Popular Posts

Site search

Follow Us

Winning Product Submissions – Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner

Written by on Sunday, April 8th, 2007 Print This Post Print This Post

The teleconference event Winning Product Subsmissions–Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST.  The audioconference will address the following:

  • The importance and underlying principles of the FDA drug development process from Phase I through market approval;

  • How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;

  • What information about your new product should and should not be included in application packets;

  • How to effectively prepare for, and communicate during, meetings with the FDA;

  • The common pitfalls that lead to delays and non-approvable determinations ;

  • How to maintain investor confidence throughout the review process;

  • An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];

  • Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;

  • Tips on the submission process — strategies for filing and how to avoid delays;

  • The review process and related correspondence;  and

  • What’s new in compliance guidance documents.

770 total views, 1 views today


© 2008-2015 The Prinz Law Office. All rights reserved.

The Prinz Law Office | Silicon Valley, CA | Los Angeles, CA | Orange County, CA | San Diego, CA | Atlanta, GA | Tel: 1.800.884.2124

Mailing Address: 117 Bernal Rd., Suite 70-110, San Jose, CA 95119; Silicon Valley Office: San Jose- 2033 Gateway Place, 5th Floor, San Jose, CA 95110 (408)884-2854; Los Angeles Office: 3110 Main St., Building C, Santa Monica, CA 90405 (310)907-9218; Orange County Office: 100 Spectrum Center Drive, 9th Floor, Irvine, CA 92618 (949)236-6777; San Diego Office: 4455 Murphy Canyon Road, Suite 100, San Diego, CA 92123 (619)354-2727 Atlanta Office: 1000 Parkwood Circle, Suite 900, Atlanta, Georgia 30339 (404)479-2470

Biotech Lawyer & Attorney: Serving Silicon Valley, San Jose, San Francisco, Santa Cruz, San Diego, Los Angeles, Orange County, Irvine, Anaheim, Santa Monica, Silicon Beach, Santa Barbara, Sacramento, Atlanta. Licensed in California and Georgia.
Follow

Get every new post delivered to your Inbox

Join other followers