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News from the FDA
Guidance Discusses Bundling Device Submissions
A recently released guidance titled “Bundling Multiple Devices or Multiple Submissions in a Single Submission” is intended to answer frequently asked questions about the FDA's policy on bundling multiple devices or multiple indications in a single premarket submission. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the bundling policy takes on additional importance because of the fees that are now associated with certain submissions as well as the performance goals the agency has committed to meet. The guidance is being issued as final for immediate implementation. A copy of the guidance document may be obtained at the Center for Devices and Radiological Health (CDRH) Web site at http://www.fda.gov/cdrh/.
Law Firms are Reducing Redundant Real Estate by Bringing Support Services Back to the Office
A trend analysis of the benefits and challenges of bringing back administrative, word processing and billing services to law offices.
New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
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.