21 CFR part 11 Update

Folks, it looks like some of our US regulations and guidance documents have been flagged for update by FDA….including everyone’s favorite, 21 CFR part 11 (source Cerulean’s email newsletter). I don’t anticipate major changes, just clarification on their intent.  Everyone enjoy your Friday.

New Guidance Agenda for 2009 Released by FDA

The FDA’s CDER has published its list of expected guidance documents and revised regulations to be issued this year (2009).

Readers of our 2009 forecast will find many items on the list familiar:

· 21 CFR Part 11

· Process Validation

· Adaptive Clinical Trial Design

· Contract manufacturing

· Various marketing, promotional and labeling guidance

· “Dear Healthcare Professional Letters” for recalls

TJK

Advertisements

2 Comments

  1. TJ, I’m flattered that you included this on your blog.

    If you’d like, I’d be more than happy to put you on my “keep me up to date on new publications and events by Cerulean” list. You won’t get more than an email or two a month, but it might be of interest to you see recent articles, etc.

    Let me know at your convenience. john

    Like

    Reply

    1. Hi John,

      Thanks for stopping by. I just saw your comment now (over a month later) as it was hung up in my queue. I’d very much like to be on your list. Best,

      TJK

      Like

      Reply

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s