Monday, March 12, 2007

FDA regulation - around the horn

I've been asked before to blog on health care and the Pharma industry, and accused of being unwilling to subject my own industry to scrutiny. The truth is, it's difficult for me to write about something that I'm entrenched in, because I don't know when to stop. Also, there are other, better bloggers than I who've attacked this subject, so I'm using this spot to highlight them.

I have written a little on this, and here is my Amazon "How to" on this subject. My writings for RAPS are here (membership required)

Piper Report. Kip Piper has a blog and an Amazon "How To" also.

Other good blogs include these:

Drug Channels
Eye on FDA
Gooz News
Orange Book blog
Pharma Marketing Blog

Other great links to the industry:

ASQ, American Society for Quality. Look for special interest groups in biomedical, pharmaceutical, and foods/drugs/cosmetics.

Barnett International. Lots of $$ courses.

BIO, BioTech Industry Assn.

BioPortfolio Biotechnology and Pharmaceutical Press Release News and Headlines.

BioSpace. News, calendar and comments by region and industry and company. Calendar. San Diego, CA.

DIA, Drug Information Association. Best job board in the industry.

FDA website.
FDA Advisory Committee Meetings. Watch Agency and industry science work together.
Center for Devices and Radiological Health: FDA CDRH

Center for Drug Evaluation and Research: FDA CDER
FDA News Digest, FDA News Digest is a free newsletter that presents the latest FDA information. Sign up at the above URL, go to browse, and search for FDA- NewsDigest -L.

FDANews: FDA News: FDA News FDA News has free daily bulletins; annual fees apply to access some links. If there's a story that interests you, you can often find it for free; use the keywords to search for the story on FDA's website or in reputable papers.
FDAAA, FDA Alumni Association. For former FDA'ers, and current ones as associate members.

FDLI, Food and Drug Law Institute. An educational network of FDA lawyers.
FDLI’s SmartBrief. Free. Other related newsletters at
Federal Register. The Federal "daily newspaper." Find out what your government is doing. Sign up to freely receive the daily Federal Register Table of Contents via e-mail.

Findlaw. For lawyers and other people who want to keep track of what this branch of the government is up to, have court summaries and full text links emailed to you.

Freedom of Information: FOI services summarizes documents released by FDA (some of which are available free on the FDA site). It also publishes a "Free Document of the Week."

GBTC Greater Baltimore Technology Council: The GBTC works to grow the region's tech community.

Hogan and Hartson (law firm) FDA related events.

IIRUSA, International Institute for Research - USA.

IQPC, International Quality & Productivity Center.

JHU Government related symposia. This includes a list of some of the other think tanks and other organizations that have public meetings regularly in the DC area for discussions on politics and government.

Maryland Hi Tech Council. The Technology Council of Maryland (TCM), founded in 1986, is an association of technology firms, federal laboratories, education institutions and business support firms that collectively form Maryland's technology community. TCM represents thousands of knowledge-based employees in the state and region.

MdBio, Maryland BioTech Industry Org. A private, non-profit corporation that offers a variety of programs to advance the commercial development of bioscience in Md.

New York Times on FDA. Read the latest stories in the free paper with the best FDA coverage. Registration required.

PDA, Parenteral Drug Association. An educational association, very active on manufacturing issues.
PDA local chapter in DC Metro. This chapter has good meetings but unfortunately
a website that is not updated frequently. Get on their email list if you don't
see anything coming up.

PDA local chapters nationwide. These PDA meetings are short, cheap, and nationwide.
Pharmacy Times On line "quick course" with regulatory emphasis.

PQRI, Product Quality Research Institute.

RAPS, Regulatory Affairs Professional Association.

San Jose (CA) BioCenter.

Thompson Publishing Group News. Free newsletters, but links of additional news are for subscribers. If there are stories that interest you, use the keywords to search for the story on FDA's website or in reputable papers.

WA Bio, Washington (State) Bio.

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