Blogs about: Fda Warning Letters
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Another IRB, Another FDA Warning Letter
FDA is keeping up its scrutiny of Institutional Review Boards with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own … more →
Carl's Blog on FDA Stuff
Another IRB, Another FDA Warning Letter
Carl's Blog on FDA Stuff wrote 5 days ago: FDA is keeping up its scrutiny of Institutional Review Boards with a Warning Letter to the Burzynski … more →
FDA Hits ICON with Warning Letter for J & J Studies
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Carl's Blog on FDA Stuff wrote 1 week ago: FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for ma … more →
Centra & Teneo IRBs Receive FDA Warning Letters
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Carl's Blog on FDA Stuff wrote 2 weeks ago: OK, I said that I was going to take a break until New Year’s. However, the letter to the Teneo … more →
FDA Warning Letters Hit Candy Cigarettes & Clinical Investigator
Carl's Blog on FDA Stuff wrote 1 month ago: FDA’s new Tobacco center put out 14 Warning Letters to internet purveyors of candy cigarettes. … more →
FDA Form 483, Inspectional Observations: Deadline for Response
Carl's Blog on FDA Stuff wrote 2 months ago: The Form FDA 483, Inspectional Observations, is the first step on the road to most FDA enforcement a … more →
FDA's Dr. Hamburg Speaks to RAPS in Philadelphia
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Carl's Blog on FDA Stuff wrote 3 months ago: Dr. Margaret Hamburg, the new FDA Commissioner spoke to about 1,000 people attending the annual meet … more →
FDA Sends J&J a Warning Letter for clinical trial failures as a sponsor
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Carl's Blog on FDA Stuff wrote 3 months ago: Johnson and Johnson received a Warning Letter from FDA for their failure to properly supervise clini … more →
A Question of Significance: Dr Hamburg & FDA Enforcement
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Carl's Blog on FDA Stuff wrote 4 months ago: Since January of 2001 FDA has been lax in protecting the public and enforcing their regulations. I w … more →
Dr. Hamburg says that FDA will step up "effective enforcement"
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Carl's Blog on FDA Stuff wrote 4 months ago: In a speech to the Food and Drug Law Institute Dr. Margaret Hamburg, the new FDA Commissioner, outli … more →
FDA Changes Website for clinical trial information
Carl's Blog on FDA Stuff wrote 4 months ago: The FDA announced that it has changed its website and that links for GCP documents might no longer w … more →
FDA warning letter or recall?
abhishekkatiyar wrote 5 months ago: Some Facts Of the 74 warning letters issued in 2007 32% contained citations with respect to improper … more →
New FDA Commissioner wants to "enforce the Act."
Carl's Blog on FDA Stuff wrote 6 months ago: Update 3: The government columnist for Applied Clinical Trials, Jill Wechsler, writes about the incr … more →
FDA Takes on Swine Flu "Cures" on Updated Webpage
Carl's Blog on FDA Stuff wrote 6 months ago: FDA has been issuing warning letters to companies trying to cash in on concerns regarding the swine … more →
FDA Warning Letters to Pharmaceutical Companies in 2009
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abhishekkatiyar wrote 6 months ago: Warning Letters and Untitled Letters to Pharmaceutical Companies in 2009 here you will get the follo … more →
FDA clinical trial standards: Is there a serious problem with Phase III studies?
Carl's Blog on FDA Stuff wrote 7 months ago: One of the first things I look at when I audit a clinical trial is whether or not the participants m … more →
DSI Hits Hard on Human Subject Protection
Carl's Blog on FDA Stuff wrote 9 months ago: The Division of Scientific Investigations (DSI) in FDA’s Center for Drug Evaluation and Resear … more →
FDA Warning Letter: A Weighty Matter
Carl's Blog on FDA Stuff wrote 9 months ago: The most common citation on FDA Warning Letters to clinical investigators at clinical trial location … more →
Supervisory Responsibilities of Investigators
Carl's Blog on FDA Stuff wrote 10 months ago: As I learn how to use the Blog I have learned I can place internet links on my pages to the right, b … more →
What's up at FDA?
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Carl's Blog on FDA Stuff wrote 10 months ago: This blog will attempt to discuss some of the changes that are taking place at FDA and (hopefully) h … more →
