The Public Inspection page on FederalRegister. The Public Inspection page may also include documents scheduled for later issues, at the request of the issuing agency. The President of the United States manages the operations of the Executive branch of Government through Executive orders. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations.
|Published (Last):||4 October 2014|
|PDF File Size:||16.36 Mb|
|ePub File Size:||8.49 Mb|
|Price:||Free* [*Free Regsitration Required]|
FDA asks that all sponsors begin using these new FDA forms h and immediately; however, it can be difficult to tell if you have the current version of these forms because FDA did not update the expiration date for either document. If you already have a copy and are trying to determine if it is the current version, here are some tips to identify the current version of the forms.
Agent DUNS. Box 6 on page 1 has been replaced with Box 6A and Box 6B. We recommend that you begin using the current version of these new FDA forms h and immediately in all of your eCTD submissions.
Using an outdated version of these forms could place your submission at risk of a technical rejection by FDA. Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.
New FDA Forms h and Posted on Mar 21, 0 0. Like this: Like Loading Join our mailing list. Follow Synchrogenix on Twitter My Tweets.
Regulatory Update: Identifying Relevant Manufacturing Sites in FDA Submissions
New FDA Forms 356h and 1571
What is USFDA form 356h?