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1. US FDA/CDRH: Guidance for Industry: Designation of Special ...
On November 10, 2008, the Food and Drug Administration (FDA) published a final rule in the Federal Register, entitled “Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex” ...
2. Young Australian Skeptics » Blog Archive » ‘Sixteen Reasons to ...
The prevalence of a phenomenon says nothing regarding its effectiveness. Furthermore, the fact that homeopathy is ‘only now gaining acceptance in the US’ is not a reason to trust the remedy, but rather one for mistrust and skepticism, ...
3. Worth A Glance » Quackery
There are many legitimate and potentially beneficial instances of information security technologies, just as there are many legitimate and potentially beneficial drugs, but the safety and effectiveness of either of these technologies ...
4. FDA Law Blog: The Unusual Case of the “MC-to-PC” Orphan Drug...
No part of FDA Law Blog --whether information, commentary, or other-- may be attributed to HPM's clients. Readers should be aware that HPM represents many companies in the food, drug, medical device, and health care industries, ...
5. Dissecting Merck’s “Gardasil for Boys” FDA Application | BNET ...
One interested party that definitely sees this as cost-effective is Merck. As BNET noted recently, Merck’s vaccine divisions are struggling to get product out the door, and they need extra indications for drugs that are mandated and ...
6. Diabetes Technology Blog: Ask FDA to Better Serve Diabetes Patient ...
The FDA's job is to protect the safety of patients in its use of drugs and medical devices and to advance public health by speeding innovations that make medicines and technology more effective, safer and more affordable. ...
7. Pfizer to Study Efficacy of Electronic Drug Side Effect Reporting ...
Although drug safety experts are optimistic about the project, they warn that its effectiveness hinges on the FDA receiving the information and on the agency conducting further studies to evaluate the validity of the reports. ...
8. Dr Kearney: Allergan Breast Implants FDA Approved
The result: The FDA has evaluated Allergan's Core Clinical Study data at four years and determined that INAMED® Silicone-Filled Breast Implants are safe and effective for use in breast augmentation and breast reconstruction. ...
9. FR Doc E8-31213
In this rulemaking, FDA has determined that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and that there is sufficient information to establish special ...
10. US FDA/CDRH: Guidance for Industry and FDA Staff: Class II Special ...
Guidance on the content and format for abbreviated and traditional 510(k)s is available at http://www.fda.gov/cdrh/ode/guidance/1567.html. Information regarding the use of standards can be found in section 514(c)(1)(B) of the Act (21 ...