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Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget

Thursday, August 5th, 2010

You know you are getting old when the FDA knows more about Facebook than you do! In a July 29, 2010 letter to Novartis, FDA cited violations with regard to a “Facebook Share” social media widget that generates Novartis-created information for Tasigna that can be shared with Facebook users (i.e., “shared content”). FDA said: “The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug.” To help the recipient of the letter — Lisa Drucker, Director, Regulatory Affairs — understand what a Facebook Share social media widget is, the letter includes several footnotes quoting information from Facebook: “Facebook Share is a way for users of Facebook to share articles, pages, video, or flash content of a site with other Facebook users.

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Curse of the Plastic Tubes

Thursday, April 29th, 2010

In keeping with the problem discussed here (“sticky containers”), there’s a report that a lot of common spectrometric DNA assays may have been affected by leaching of various absorbing contaminants from plastic labware. If the published work is shown relative to control tubes, things should be (roughly) OK, but if not, well.

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Recommended Books For Medicinal Chemists, Part One

Monday, November 23rd, 2009

I asked recently for suggestions on the best books on med-chem topics, and a lot of good ideas came in via the comments and e-mail. Going over the list, the most recommended seem to be the following: For general medicinal chemistry, you have Bob Rydzewski’s Real World Drug Discovery: A Chemist’s Guide to Biotech and Pharmaceutical Research

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Retire These Reactions!

Thursday, October 8th, 2009

Here’s a question you don’t hear discussed very often: are there some synthetic organic chemistry reactions that don’t need any more work? I’m moved to ask this because I just came across yet another way that someone has reported to dehydrate an oxime to a nitrile. (No, I won’t link to it.

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FDA Reads My Blog: Declares Latisse Web Site Misleading

Thursday, September 17th, 2009

On September 10, 2009, the FDA sent Allergan a notice that its Latisse Web site was misleading (see ” FDA Says Allergan’s Web Site for Eyelash Thickener Is Misleading “). The letter states: “the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the “FAQs” and “About Safety” pages of a consumer website and a “Launch display timeline” (timeline) (APC36ON09) for LatisseTM (bimatoprost ophthalmic solution) 0.03% (Latisse) submitted by Allergan, Inc. (Allergan) under cover of Form FDA-2253

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Are Organic Search Results Next on FDA’s Chopping Block?

Monday, September 14th, 2009

In April, the FDA sent warning letters to several pharmaceutical companies citing paid search engine ads that it claimed to violate FDA regulations (see ” FDA’s Actions Speak Louder than Its Words: On the Internet It’s the Medium as Well as the Message! “).

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Word For Word – But Why?

Wednesday, June 10th, 2009

I missed this a couple of months ago, but there was a paper withdrawn from the Journal of Organic Chemistry . The original is here , a contribution from the Indian Institute of Chemical Technology in Hyderabad on 2-aryl benzothiazoles

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Blogroll Update

Friday, May 8th, 2009

I’ve finally, at long last, updated the blogroll to include a lot of sites I should have included.

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Altermune – Real Stuff or Not?

Friday, May 8th, 2009

Kary Mullis is an outlier among Nobel Prize winners.

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