by Tony Chen
If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you. Here’s our list of the top 40 online destinations on the FDA and some of the key industries it regulates. We applied only one criteria to make it on this list: free, up-to-date, and valuable content.
Blogs and websites exclusively covering the FDA
- EyeonFDA – Does this guy ever sleep? Written by Mark Senak, this blog is updated multiple times a week and focuses on the approval and marketing of new drugs. Read his infamous quarterly summaries of warning letters.
- FDAmatters – Updated a few times a month, Steven Grossman provides unique insight on the FDA and related policy (he spent 4 years working at the HHS). Recently did a nice SWOT analysis on the FDA.
- FDA Lawyers Blog – a tagteam effort by some of the lawyers at FLH, they provide daily coverage of various legal matters concerns the FDA. Interesting read: India’s going to start inspecting overseas manufacturing sites, too.
- Assurx Blog – if your day job involves compliance, risk, or quality, these folks got you covered. Recent fav: their 2011 forecast for the FDA.
- FDA Law Blog – yes, another tagteam effort by lawyers at HPM. Nice FDA legislation tracker in the sidebar.
- FDA’s Transparency Blog – Yes, the FDA itself is really trying to open up and this blog is a central part of it. Updated roughly once a week, you’ll get the typical press releases but also some sincere requests for comment.
- MedPageToday’s FDA page - This page is really easy to scan once every few weeks to make sure you didn’t miss any big news.
- Compliance Zen – Written by compliance guru John Avellanet, this blog provides insights into “lean compliance,” QbD, audits/inspections, and other leadership tactics.
- FDAzilla - surprise! Yes, we’re mentioning ourselves. We’re proud of the fact that we’ve taken huge FDA databases, put them online, and made them much more usable and searchable. Check out Drugs, Devices 510ks & PMAs, MAUDE, FDA employees, and 483s. And you ain’t seen nothin’ yet.
- GxP Perspectives – Blogger Carl Anderson, an 18-year-vet of the FDA, is a consultant and does mock FDA audits. Recent hit: Building a culture of compliance.
Pharma / Biotech Blogs and Websites
- FiercePharma and FierceBiotech – great industry coverage via their website and a free email newsletter. These guys are on top of things. I see more and more news organizations and blogs linking to here.
- FiercePharmaManufacturing – Great industry coverage on the FDA, manufacturing, supply chain issues, and GMP. Free newsletter that goes out twice a week. Recent hit that got tons of attention: FDA warning letter language to watch.
- PharmaLot – informal tone + personality + the seriousness of issue coverage = great & rare combo.
- The QA Pharm – Who is this masked man? An anonymous quality executive consulting in the pharma industry shares on his insights with zip and humor. You can tell that he just loves to write.
- Pharm Exec Blog - coverage on global pharma topics, especially across the pond in the EU. This one was fun: what keeps the C-suiters up at night?
- AZ Health Connections – Blog sponsored by AstraZeneca. If anything, it’s interesting to see where they take this as we all wait for more social media guidance from the FDA.
- Pharma Marketer – DTC, social media, regulatory, digital marketing and more – updated multiple times a day with almost 20 well-known contributing authors.
- Pharma Marketing - With a sense of humor and good reporting, John Mack covers all things marketing in Pharma, including this recent post of the 10 Most Important, Awesome Pharma Highlights of 2010
- Pharma Manufacturing – Usually these trade publications are overly stuffy, but this one ain’t, as evidenced by their new funny pharm segment.
- In the Pipeline – Derek Lowe, PhD (in organic chem!) has been blogging for 9 years (which is about 75 years in blog years) on drug discovery and the pharma industry.
- Coreynahman.com - A nice running list of curated items around pharma - about 5-10 new items/day. The site is getting around 50,000 visitors/month. Worth a quick scan to make sure you haven’t missed anything.
- PharmaLive (FDA tagged) – another good newsfeed around pharma related to the FDA.
Medical Device Blogs and Websites
- MassDevice – Though there’s a slight emphasis on the New England region, this is a great resource for the latest on devices. They’ve also got several blogs that go more in-depth on such topics as compliance, marketing, and exports. A breath of fresh air in the industry.
- Medical Device Today – business strategy, regulatory, innovation, and investment news – great one for the business side of medical devices.
- FierceMedicalDevices - free, weekly newsletter that goes out to 10,000+ people in the medical device and diagnostics industry. Recent hit: industry reacts to 510k reform ideas.
- MDCI Blog (FDA-tagged) – MDCI is a prominent CRO that has a has a 10-person blogging team covering medical devices – from medical device labeling to the FDA CDRH’s take on their own goals.
- Drug and Device Law - Lawyers from Dechert offer their personal perspectives on all things associated with product litigation. What I like about this best is their ruthless and systematic dissection of rulings and legal decisions, like this one related to KV pharmaceuticals.
- Medgadget - more for fun than for work, Medgadget covers all kinds of medical devices and emerging medical technologies from a consumer/business perspective.
- Food Safety News - This is the only one I go to. Know of any other good ones?
Groups, Social Networks, and Facebook Pages Related to the FDA
- CafePharma - a social network for pharma sales folks. Should’ve called the site phacebook (sorry, couldn’t resist). In all seriousness, this site gets hundreds of thousands of views/month. Recent: sales rep asks for advice when boss moves in 3 houses down and embarrassed to be in pharma.
- FDA on Facebook – It’s now up past 3,800 fans, and is growing 120 new fans every week.
- FDA Inspections Linkedin Group – My sense for a lot of LinkedIn groups is that everyone joins them all and posts the same links to all the groups they’re a part of. This one actually stays on topic, is relatively spam-free, and has lots of good links and resources.
Twitter and the FDA
- FDA Tweets – The FDA has created 8 distinct twitter accounts – this is an aggregation (via a twitter list) of them all.
- Pharma Company Tweets – curated by EyeonFDA. As more and more pharma companies realize they need to do more than dip their toe in social media, this will be an interesting, rapidly evolving feed to watch.
- Beth Martino’s Tweets – She’s the only FDA employee that I know of who’s tweeting “on the side”. She’s the Associate Commissioner of External Affairs.
- @GCPWorks – Tina Avanzato Chiodo, former compliance exec of ImClone, tweets all about compliance and clinical good practices. Very focused and insightful.
- @RAPSorg - Yes, the official twitter account for the Regulatory Affairs Professional Society. There’s no 1 twitter account that I retweet more than them.
- @eyeonFDA - apparently when Mark Senak is not blogging about drug approval & marketing, he’s tweeting.
- List of 10 tweeters who talk about contract biopharma services. These biotech folks know their craft well.
- FDAzilla’s Favorites – most of the folks on this top 40 list aren’t on twitter yet. The ones that are I’ve compiled into a twitter list called Working Smarter with the FDA. Here’s a snapshot:
One more for fun: What did the FDA website look like back in 1996? Check out it’s evolution on the wayback machine.
What free, up-to-update, valuable sites do you lean on for intelligence on the FDA?
March 2011 Update: check out @FDA483s on twitter - all about avoiding Form FDA 483s.