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Drug & Device News
FDA to Streamline Common Review Path for Medical Devices
The Food and Drug Administration (FDA) announced Jan. 19 that it intends to implement a new 25-point plan to improve the path to market for certain medical device products. The system will include a new Center Science Council made up of senior FDA experts whose job will be to ensure timely and consistent science-based decision-making. Under the new plan, de novo review of some innovative, lower risk medical devices will also be streamlined. The changes to the submission process for 510(k)s (so-called for the section of the Federal Food, Drug, and Cosmetic Act that describes this process) are being implemented because industry players working to obtain pre-market approval for low-risk devices (such as catheters and diagnostic imaging tools) found the old system unpredictable and confusing. Consumers and health care providers criticized approvals under the old system for not being rigorous enough. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH), says the planned changes will create “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.” For more information on specific changes to the approval process, go to: http://www.fda.gov/About
FDA/CentersOffices/CDRH/CDRH Reports/ucm239448.htm
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Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
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Bit Parts
Summary Judgment Denied Defendant in Declaratory Action by Producer of To Kill a Mockingbird Broadway Play Seeking Amateur Theatrical Rights
Risks of “Baseball Arbitration” in Resolving Real Estate Disputes
“Baseball arbitration” refers to the process used in Major League Baseball in which if an eligible player's representative and the club ownership cannot reach a compensation agreement through negotiation, each party enters a final submission and during a formal hearing each side — player and management — presents its case and then the designated panel of arbitrators chooses one of the salary bids with no other result being allowed. This method has become increasingly popular even beyond the sport of baseball.
Disconnect Between In-House and Outside Counsel
'Disconnect Between In-House and Outside Counsel is a continuation of the discussion of client expectations and the disconnect that often occurs. And although the outside attorneys should be pursuing how inside-counsel actually think, inside counsel should make an effort to impart this information without waiting to be asked.