GxP Perspectives: Summer Reading

July 25, 2011

GxP Summer Reading

Summer Reading for GxP Professionals

GxP Perspectives firmly believes that summertime means more vacations, less work, and some different recommendations for your reading list. I am actually going to NOT be traveling for the entire month of August. I have weeds to pull, a fence to paint (can Tom Sawyer give me a call), Some hiking to do, and a blog to keep up (to a certain degree). Like most of you, I also enjoy reading. So here are some of my favorite sites for your perusal. Some are industry, some are not. All of them are good. I have really been enjoying the Harvard Business Review “Management Tip of the Day.” If you have other suggestions, please let us know.

UPDATE: Dr. Hamburg’s Op/Ed article printed in the Wall Street Journal.

7 August Update: Not to be missed is the Essex IRB Warning Letter. Earlier this year FDA warned of a fictitious submission to central IRBs. Essex took the bait and approved the fictitious submission.

Harvard Business Review Management Tips is a daily, very brief, “tip of the day.” I find them useful, well-written, and usually making sense. They have many products that they would like to sell you.

What I watched Last Night is a periodic, non-commercial blog about movies. No, not current Hollywood fare, but movies that this acclaimed video maker and film critic actually enjoys. It’s summertime and what better season to watch a movie.

MedCity News A weekly compilation of articles on this commercial website.

AbsoluteArts Because we all need some art in our life.

GCP works The twitter account of GCP Professional Tina Avanzato Chiodo.

NYRblog The blog of the NY Review of Books. If I could only subscribe to one print journal it would be the New York Review of Books.

PharmTech Talk is the blog of Pharmaceutical Technology. All play and no work…

Guardian.co.uk from London. The Guardian provides a different news perspective for readers from the U.S. who can see what others think of us. I like the column from Hadley Freeman on the ratings downgrade. The Guardian has a lot of very good writers.

Science 2.0 Now featuring “Decapitation and the Wave of Death” (now how cool is that?)

Value Added Connects: This blog from India discusses the inspections of CROs by the DCGI (Drugs Controller General of India). A good way to learn more about clinical trials in India.

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Please leave your comments on summertime reading


Top FDA, Health, and Science Blogs

September 8, 2010

FDA health science blogs

Hamlet and Yorick Discuss FDA Compliance, Health,
& Science Blogs

Here are some interesting blogs on the topics of FDA regulated industry, FDA regulations, health and science that regular readers of GxP Perspectives might enjoy while I am on vacation. Everyone should have a vacation now and then and I am going off for almost two weeks!

Acronym Required states they follow science and industry but don’t tell a lot about themselves. Interesting reading.

Applied Clinical Trials: Their blog is one of the best. Take their salary survey.

Chemistry Explained: A good site on a dry topic. Not an actual blog.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

Diabetes Self Management Well organized and informative

Drug Health Supersite An eclectic mix.

Endocrine Today: “Clinical news on diabetes and endocrine disorders.”

Eye on FDA: Not my favorite but an important blog on FDA stuff.

FDA Law Blog: As described

FDA Matters: Feisty blog on FDA from Steven Grossman

GxP Lifeline: A Master Control Newsletter (commercial content and GxP news)

Medical Devices Today: From Elsevier (not feisty)

Partners in Health Blog: News about the health organization’s work in Haiti.

PharmaGossip: We all need a little gossip in our lives. This blog has the longest blogroll I have ever seen (almost). Blogs that everyone has heard of and that no one has heard of.

PharmTech Talk: Pharmaceutical Technology’s excellent blog.

Two Decades and Counting: A GxP professional’s blog that is well worth checking out.

WSJ Health Blog: A good blog from a newspaper that I don’t read.

FDA blog health science

Hamlet Should Have Taken More Vacations

On my return I hope to have a post on the new FDA Guidance: FAQ for IVDs. I also have several Guest Commentaries lined up on the TMF reference model, informed consent, and more! And as for Hamlet and Yorick, Hamlet never said that he knew him well. He did say that Yorick was, “a fellow of infinite jest, of most excellent fancy.” Sounds like a “to be” kind of guy. Unfortunately, the Hamlet of Ashland 2010 left a little to be desired. Oh well.

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Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA.


One year for the Blog

February 16, 2010

This blog started on 16 February 2009 as “Carl’s Blog on FDA Stuff.” At the time I said:

“This blog will attempt to discuss some of the changes that are taking place at FDA and (hopefully) helpful interpretations of regulations and guidance documents. Future posts will include an analysis of Bioresearch Monitoring Warning Letters. For example, have people been noticing the large increase in Warning Letters issued by CDER/Division of Scientific Investigations in the past two years or so?”

Time marches on and the focus of the blog has moved towards trying to craft some meaningful perspectives for GxP professionals and members of the public who are interested in commentary on the life science industry, clinical trials, and (of course) FDA.

GxP Perspectives: I’m going to make a few more changes to the blog in the next few weeks and soon will be including guest commentaries by GxP professionals on different aspects of our business. What I don’t know could fill a book (maybe two) and I want to hear from others on the practical issues that we face, such as electronic medical records, GLP issues, pharmacovigilance, interpreting guidance documents, and just what belongs in a trial master file. If you are interested in submitting a guest commentary, just add a comment indicating your interest and I will get back to you. (WordPress provides me with the email of anyone who comments which is not made public.) I am interested in hearing what you have to say.

I’ve also started inserting some photos and graphics, we don’t want the Blog to be too boring.

Carl's Blog on FDA and GxP

The stature of Peter Pan, London, one of the blogster's role models:)

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Blogroll: For those of you interested in the financial aspects of our industry – and others – Check out Hedge Hodge at:

http://www.hedgehogs.net/


The Blog Cleans Up Its Act

January 7, 2010

Welcome to Carl’s Blog on GxP Stuff. I’ve changed the name from “Carl’s Blog on FDA Stuff” to reflect my evolving interest in focusing on a number of issues and not being “FDA-centric.” There many other regulatory agencies in the U.S. and the rest of the world and I would like to give them some attention as well.

Also, its the new year and I’m finally figuring out how to use some of the WordPress blog features. As a result, I have cleaned up the Blogroll so that links once more make sense. I have moved many links to “Interesting Articles” and have created a new category for “FDA Stuff” that are links to the nooks and crannies of FDA’s website. Yes, I will still be discussing FDA.

This allows me to organize and highlight some of the interesting places you can go to research FDA & GxP stuff. I’ve just added Compliance Zen to the Blogroll. The author, John Avellanet, has an excellent post on communication (which I should take to heart). I’ve also moved the Blog’s very own book reviewer’s excellent website for food safety, 1 FDA, Food Safety, and Related Topics, to the top of the Blogroll. Thanks Sid. Another post worth reading is by Lisa Henderson at the Applied Clinical Trials Blog. She has some interesting things to say about when her trade publication’s sales and editorial staff started sharing the same office location.

Finally, I want to recommend some blogs/sites that are not directly related to GxP or FDA stuff. These include France 24 which is an English language news station from France. I think it is important to see things from outside the U.S. We all know about BBC but France 24 is very interesting. Also there are two blogs put out by individuals who take the time to write thoughtfully on topics that you may, or may not, find of interest. They are: Grab & Keel which focuses on current events from the author’s perspective and Monte’s Blog which takes a look at one person’s spiritual journey. Also there is Water: USGS that provides a perspective on government service and one of the most important issues we will face this century, water. Now that I am GxP I can give this issue some thought. Please scroll down and take a look at the various links. There are a number of different perspectives so you can take a look at various viewpoints. Feel free to leave a comment and suggest other sites that you find of interest.

UPDATE: This news is just in from Alan Andersen in an email to members of the FDA Alumni Association:

“FDA has announced Ralph Tyler as the new Chief Counsel. He is currently serving as the Insurance Commissioner of the State of Maryland (01/08/10 is his last day, I think) and will be joining FDA on January 19.

Tyler served as Chief Legal Counsel to Maryland Governor Martin O’Malley and as Baltimore City Solicitor. He was a partner in the international law firm Hogan & Hartson, L.L.P. Prior to that, he served in the Maryland Attorney General’s office from 1982 through 1996, holding the titles of Deputy Attorney General, Chief of Litigation and Assistant Attorney General. Acting Chief Counsel, Mike Landa, will return to his position as Deputy Director for Regulatory Affairs at CFSAN.”

ALSO: Here is the link to an article about clinical trials in the UK that I found interesting:

http://www.ft.com/cms/s/0/2b66d8ae-f570-11de-90ab-00144feab49a.html?nclick_check=1

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Life after the Coast IRB sting: What should we do about IRBs?

July 21, 2009

I was discussing the Coast IRB sting operation by the Government Accountability Office (GAO) with some quality assurance colleagues the other day. Quality Assurance departments at biopharmaceutical and medical device companies are starting to scrutinize the institutional review boards (IRBs) that they contract with or that clinical sites use to review research. FDA requires sponsors to obtain assurances from clinical investigators (on the Form FDA 1572 or Investigator’s Agreement) that they will obtain approval from an IRB that meets the requirements of 21 CFR Part 56 (the IRB regulations).

The closure of Coast IRB impacted approximately 300 clinical trials and 3,000 clinical sites conducting the studies. Coast had approved a phony study submitted to them by the GAO. Two other IRBs refused to approve the study but Coast did. They are now out of business and a lot of people are scrambling to make sure their studies and their data aren’t negatively impacted by the closure. It is understandable that there is considerable concern. However, there will be a lot of false assumptions made by the Coast sting and a lot of wrong conclusions drawn from the case. Here are some of my preliminary thoughts:

1. The IRB regulations are hopelessly outdated. When they were written commercial IRBs like Coast weren’t really imagined, let alone accounted for. IRBs were supposed to be ethics committees for a specific institution at a specific location, such as an academic medical center. They were led by volunteers and there frequently wasn’t even an administrative fee for submission of a protocol. They were also slow and cumbersome. That’s one of the reasons commercial IRBs came into existence.

To make matters worse, IRBs are regulated both by FDA and the Office of Human Research Protection (OHRP), in the Department of Health and Human Services for NIH and other government funded research. Although the regulations are very similar, there are some differences and OHRP regulates IRBs much differently than FDA. Most academic medical centers depend on NIH funding so they follow the OHRP regulations very closely.

2. The regulatory relationship is between the investigator and the IRB, not between the sponsor and IRB. Many of the traditional institution based IRBs won’t even talk to the sponsor. However, things have changed. Many studies are conducted outside of the traditional institutional setting and many sponsors prefer to work with a commercial IRB because they are faster and, in the opinion of many, more efficient. Clinical trials are expensive and the ability to work directly with an IRB on informed consent forms and protocol amendments is very appealing to sponsors and investigators alike.

3. IRBs aren’t supposed to monitor clinical trials, sponsors are. However, many are suggesting more and more responsibilities be assigned to the IRB. This can be a problem for a variety of reasons. An academic IRB may be slower if OHRP decides to enforce regulations in a strict manner. Their funding depends on it. NIH can put stricter enforcement standards in their proposals. For FDA to require commercial IRBs to do more supervision there would need to be a revision of the regulations. That can take a lot of time.

In the mean time, sponsors are wondering how they qualify and supervise their contract IRBs. There is only one place that gives them any clout in FDA guidance documents and regulations. The very last sentence of Section 3 in E6, Combined Guidance for Good Clinical Practice states the following:

“The IRB/IEC may be asked by investigators, sponsors, or regulatory authorities to provide copies of its written procedures and membership lists.”

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The Blog enters the world of movie reviews

May 11, 2009

When you are the author of an internationally famous Blog on FDA Stuff and you’ve had over 200 hits the past week, you know its time to take on Hollywood. I just saw Duplicity with Clive Owens and Julia Roberts at the Blue Mouse, the last single screen theater in the Northwest. Movies only play at the Blue Mouse after they’ve played everywhere else they possibly could. So if you want to see Duplicity you will probably have to wait to rent it.

When I first began working at FDA (a former employer), I answered the phone at the San Francisco District’s Consumer Affairs Office. One of my first calls was about a drug, now widely available, that would grow peach fuzz where men had grown bald. “When is it going to be approved?” the caller asked desperately. I soon learned that cures for baldness, along with weight loss gimmicks and impotence potions were very big business.

Which leads us to Duplicity. At first I thought it had been written by a computer geek obsessed with Part 11 of the FDA regulations on computerized records. There is a lot of security system hocus pocus that is pretty cool. Then, about three quarters through the movie, the plot thickens, so to speak. Anyway, when you want a fun, lightweight movie to rent, please consider Duplicity. It’s about industrial espionage and products that go bang in the night. Without FDA approval, I might add. I’ve added a link to the Duplicity website under the Blogroll. Have fun.


Blogs on FDA Stuff

March 8, 2009

Obviously I am not the only person with something to say about FDA. A very well organized blog with a lot of good links is Eye on FDA which I am adding to the blogroll at the right. Let me know if you have other blogs worth noting.

So I am editing this because I came across another blog on FDA stuff from another group of lawyers. This is interesting because it discusses the whole issue of FDA regulation of tobacco. The blog is called the FDA law blog and I am adding them onto the blogroll on the right. For a couple of years I was the San Francisco District Tobacco coordinator, which got me a trip to Reno, Tukwilla (Washington State), and… Honolulu. Not difficult duty. I’ll contribute soon on tobacco, because I probably disagree with everybody. Anyway, check out the blog on FDA Law. They have worked hard to put together information for us.

Another interesting blog is Grab and Keel which I have entered onto the blogroll. They discuss food safety issues (the “F” in FDA stands for food, not federal) including a house bill, H.R. 875, that would create a single food safety organization. It is a very good idea and you can check it out on the important references link to the right. Search by bill number when you get to the site.


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