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CDRH to Re-review Menaflex Device Over ‘Compromised’ 510(k)9/25/2009) CDRH will reevaluate its 510(k) clearance decision on ReGen Biologics’ controversial
Menaflex Collagen Scaffold (CS) because the original review process was compromised, according to a just-released preliminary report that investigated the Center’s decision not to require a PMA submission for the device. The
internal review was ordered (see story) in May by FDA principal deputy commissioner Josh Sharfstein after Senate Finance Committee ranking
member Charles Grassley (R-IA) raised questions about CDRH’s actions involving the device. At the time, Sharfstein said
that Grassley’s "questions and the controversy surrounding this matter raise legitimate concerns about whether
the agency’s review process and decision to clear for marketing the ReGen Collagen Scaffold were compromised."
Read more ...
9:19 am
CDRH Ombudsman Denies Amalgam Dispute Resolution Bid(9/24/2009) Citing inapposite statutory, regulatory
and guidance references, CDRH ombudsman Les Weinstein 9/18 denied a Holistic Dental Association request that the Center’s
Medical Devices Dispute Resolution Panel review FDA’s controversial 8/4 final rule classifying mercury dental amalgam into Class II. He said only a device sponsor, applicant or manufacturer
has standing for such a review under Sec. 562 of the FD&C Act, 21 CFR 10.75(b)(2) and the Guidance on Resolving Scientific
Disputes Concerning the Regulation of Medical Devices. Read more ...
Why Drug Firms Get More Fraud Probes than Others(9/24/2009) “There’s no reason to believe that the pharmaceutical industry employs
more ‘ethically-challenged’ individuals than any other industry!” Perhaps the only remarkable thing about
this otherwise unremarkable observation is the person who voiced it: the acting U.S. attorney for the District of Massachusetts
Michael Loucks, who served as chief prosecutor for the Department of Justice (DoJ) on many of the most celebrated (or infamous!)
cases of pharma wrongdoing in recent years, obtaining settlements netting tens of millions of dollars in rewards for industry
“whistleblowers,” and billions in restitution and fines for government. Read more ...
9:27 am
FDA Soliciting Comment on Internet, Social Media Promotion9/21/2009 FDA will hold a public
hearing 11/12-13 and receive written comments until 2/28/10 on issues related to promotion of FDA-regulated medical products
using the Internet and social media. A Federal Register notice announces the hearing and gives significant background on evolving use of the Internet and social media and on FDA’s
current regulation of promotional materials. Recently, FDA had been criticized for sending notices of violation to 14 drug
companies that used Google sponsored links without risk information (see story). And some individuals and organizations have called for FDA to develop new policy in this area (see story). Read more ...
1:16 pm
Hamburg’s Daunting Mission: Raising Public Respect for FDA9/21/2009 [Analysis by Jim Dickinson*] In her
warmly received 9/16 keynote address to the Regulatory Affairs Professionals Society, FDA commissioner Margaret Hamburg lamented
the agency’s current standing in public esteem. Citing a 7/10-12 Gallup Poll, she said: “I’m sorry to have report to you that FDA ranked second to last. Perhaps even more disturbing, we
ranked below the IRS! So here is my first priority as commissioner: to step above the IRS (loud, continuing applause)
and most importantly to rebuild public trust and confidence in an agency that’s critically important to the health and
wellbeing of all Americans.” Read more ...
1:00 pm
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