Monthly Archives: May 2010

FDA Forms Biosimilar Work Group

Posted on 19 May 2010 by Leo DiNapoli

In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect. – … Continue reading →

Posted in FDA, Industry News | Tagged , , , , , | 1 Comment

Bad Ads – FDA Recruits Health Care Providers to Combat Misleading Advertising

Posted on 18 May 2010 by Leo DiNapoli

If your advertising goes unnoticed, everything else is academic. – William Bernbach Fierce reported that the “FDA has issued 186 warning letters so far this year”.  (Looking at that number, they must mean “warning and untitled letters” which are frequently … Continue reading →

Posted in eCTD, Industry News | Tagged , , , , , , , , , | 1 Comment

DDMAC Sends Warning Letter Over Unbranded Websites

Posted on 17 May 2010 by Leo DiNapoli

If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis:  DDMAC Sends Warning Letter Over Unbranded Websites.  That’s right, a warning letter over websites that contained no “direct” … Continue reading →

Posted in FDA, Industry News | Tagged , , , , , , , , , , , , , | 2 Comments

Advice from the FDA, Part 2: Making Your eCTD Submission Reviewer-Friendly

Posted on 14 May 2010 by Meg Walz

Cato’s Director of Regulatory Operations, Evan Richardson, authored a guest blog post featured on PharmPro.com today.  PharmPro.com is the website for Pharmaceutical Processing magazine, offering a wealth of  information on products, technologies and applications for pharmaceutical and biopharmaceutical professionals. Evan’s … Continue reading →

Posted in eCTD, Guest Posts, Publications, Social Media | Tagged , , , | 1 Comment

Tech Council of Maryland BioBreakfast Series

Posted on 13 May 2010 by Evan Richardson

The Tech Council of Maryland (TCM), Maryland’s largest technology trade association, brings its 500 plus members access to technology industry leaders in Maryland, DC and Virginia.  MdBio, a division of the TCM, seeks to unify, empower and advance Maryland’s bioscience … Continue reading →

Posted in Conferences and Meetings | Tagged , , , , , | 1 Comment