The new FDA requirement that’s described in this press release is a bit odd.
As of now, the FDA requires that “manufacturers now must include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients.”
Lemme make sure I understood this… the FDA wants to know what diseases and conditions a manufacturer’s product is designed to treat? And a real quantifiable number of how many kids are affected by the disease that their product intends to treat?
The press release also says… “Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations. The requirements, contained in the Food and Drug Administration Amendments Act of 2007, will also improve the agency’s ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients.”
Anything that tries to fly under the banner “we’re doing it for the kids” is an automatic suspect in my book.
Is there anything wrong with this request? Not that I can see. But is it a strange request? Most definitely.
Here’s the official FDA press release on the new requirement.
Stud Capsule For Men is being recalled by the FDA because it has been “adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction(ED).”
I like how the FDA sneaks in words like “adulterated” in press releases like this. You can’t really use that word much outside of scrabble and in general character insinuations.
Anyhow, this drug is “…sold as a blister pack containing one capsule per unit of use 24-packs in a Box…consumers who have Stud Capsule For Men Lot 060607-01/060108-01 Exp 6-2010 in their possession should stop using them immediately.”
OK, seriously, if you’re taking something labeled and marketed as a “stud capsule” you really should re-evaluate some of your goals. Just sayin…
Here’s the link to the official FDA recall notice.
Whole Foods Market is recalling their Whole Catch Yellow fin Tuna Steaks because they’ve got a good chance of giving people scombroid poisoning due to high levels of histamine in the fish.
The press release from the FDA says the recall is for the Tuna Steaks “with a best by date of Dec 5th, 2010” and is “sold in twelve ounce bags with Best by Date: exp 05 DEC 2010 with Lot Code: 4853309157A and displays the following UPC code: 0-99482-42078-9 Whole Catch Yellow fin Tuna Steaks (Frozen) 12 oz.”
Scombroid poisoning isn’t any fun. This will kick in within minutes after eating the fish, and will give you “…tingling or burning sensation in the mouth, facial swelling, rash, hives and itchy skin, nausea, vomiting or diarrhea.”
Here’s the link to the FDA article.