On June 7, 2023, the Securities and Exchange Commission adopted final rule 9j-1 (“Rule 9j-1”)1 under the Securities Exchange Act of 1934 (the “Act”). Rule 9j-1 is designed to prevent fraud, manipulation, and deception in...more
As market participants debate whether the recent bank shutdowns and the government-sponsored sale of Credit Suisse may be a precursor for another “Lehman Moment,” we are reminded of yet unresolved issues that followed the...more
In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance. The guidance document is...more
On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more
Our Financial Services & Products Group provides background on how Russia defaulted on its eurobonds and discusses the implications for Russian bond and credit default swap positions....more
Michael Hsu, the acting chief of the Office of the Comptroller of the Currency, recently addressed his remarks to the Blockchain Association drawing similarities between the current growth of cryptocurrencies and...more
DC Avoids Getting Its Wires Crossed With Wirecard - Following its application to the Munich District Court to open preliminary insolvency proceedings, Wirecard was alleged to have been subject to a bankruptcy credit event....more
Hertz CDS Auction Attracts Unusual DC Action - The Determinations Committee (DC) dealing with the Hertz bankruptcy credit event received a challenge from a market participant to the inclusion of certain letter of credit...more
ISDA has reopened the CDS NTCE Protocol prior to its effective date on Jan. 27, 2020. The Protocol will remain open for adherence until noon on Friday, Jan. 24, 2020. ...more
ISDA has extended the closing date for the CDS NTCE Protocol by two weeks. The Protocol will now close on Oct. 28. This extension of the adherence period is due to the relatively modest rate of adherence so far. ...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
On August 29, 2019, an Illinois court denied a petition by a political activist and a hedge fund seeking leave to file a lawsuit claiming that approximately $16 billion of Illinois’s general obligation bonds (“GO Bonds”) were...more
In a continuing effort to address the advent of narrowly tailored credit events (NTCEs) in the CDS market, ISDA is now preparing for the implementation of the changes designed to deter market participants from running these...more
Narrowly tailored credit events have emerged as one of the most controversial opportunistic CDS strategies in recent years, as we have been reporting in prior publications....more
German Parliament adopts Brexit Transitional Act - The German Parliament (“Bundestag”) adopted by a large majority the so-called Brexit Transitional Act (“Brexit-Übergangsgesetz”) submitted by the Federal Government on...more
In this second part, we analyze two recent situations where a proposed refinancing dramatically affected the CDS market for the reference entity because of the reduction in the sell-side risk. Although these cases may or may...more
Over the past few years, the CDS market has seen an increase in activism and the evolution of creative refinancing and restructuring strategies intended to achieve particular outcomes in the CDS market....more
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
On August 10, 2015, the International Organization of Securities Commissions (IOSCO) published its final report on “post-trade transparency” in the credit default swaps (CDS) market (FR17/2015). The term post-trade...more
On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule (“PFS”) for calendar year 2016 (the “Proposed...more
End users of swaps should be aware of three impending deadlines for complying with new Commodity Futures Trading Commission (CFTC) regulations....more