Friday, May 24, 2013

FDA - Unusual Letter Sent To iPhone-Based Testing Device Co

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product:

"(FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency."  . . .

"Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter."

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Ten FDA 483s Summarized by FDAzilla Blog

Follow the link below to read FDAzilla Blog's overview of 10 recent 483s.

10 FDA 483 News Stories | FDAzilla Blog:
"Here’s 10 recent stories that have hit our radar related to FDA 483s: . . . "
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Wednesday, May 22, 2013

FDA - Don't Represent Dietary Supplements As Foods

FDA: Dietary Supplements Can't be Marketed as Foods:

" . . . If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product.""

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Monday, May 20, 2013

FDA Cites 70% of Dietary Supplement Firms on GMPs

FDA GMP Inspectors Cite 70% of Dietary Supplement Firms:

"During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request."

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Friday, May 17, 2013

Dirty Medicine - A Fortune Feature - A Must Read!

This is a must-read . . .

Dirty medicine - Fortune Features:

"On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company."


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Monday, May 13, 2013

Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

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