2BInformed: How TSCA Amendments Impact Industries and Managing the EPA’s Risk Evaluations
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Newly Amended Dual Agency Disclosure Law: Much Ado About Nothing
Amendments made by the California Office of Health Care Affordability (OHCA) to its cost and market impact review (CMIR) regulations became effective on Aug. 22, 2024, and serve to expand the scope of the Health Care Quality...more
Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more
Updated: reporting requirements for swap dealers, swap participants, and large traders in the futures and options market On April 30, 2024, in two separate releases, the Commodity Futures Trading Commission ("CFTC")...more
On November 1, 2023, the New York Department of Financial Services (NYDFS) adopted amendments to its Cybersecurity Regulation, 23 NYCRR Part 500 (Cybersecurity Regulation). This is the second amendment (Amendment) to its...more
The SEC on May 3, 2023, voted to adopt certain amendments to the reporting requirements under Form PF. Of particular interest to investors, the amendments require additional disclosure by all private equity fund advisors with...more
Requirement to appoint a Money Laundering Reporting Officer (“MLRO”) - Under the Anti-Money Laundering Regulations (Revised Edition 2020), as amended by the Anti-Money Laundering (Amendment) Regulations, 2022, and the...more
Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules...more
On Nov. 9, 2022, the New York State Department of Financial Services (NYDFS) published a proposed second amendment to its cybersecurity regulation. This follows its pre-proposed amendment that was published on July 29. ...more
In a significant regulatory change that will impact real property transactions and loan financings, the Maryland Department of the Environment (MDE) joins a handful of states that requires the reporting of historical...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more
On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more
On April 28, the Massachusetts Public Health Council (“PHC”) approved final proposed amendments to the clinic licensure regulations. The initial revisions presented by the Department of Public Health (the “Department”) in...more
Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more
Update: The decision has been appealed. On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more
EPA recently issued a final rule amending Toxic Substances Control Act (TSCA) regulations concerning “small manufacturers” of chemical substances. Companies that meet the regulatory definition of a “small manufacturer” of...more
Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. Further to our June 1, 2020 update,...more
Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more
On March 12, 2020, the Securities and Exchange Commission (SEC) adopted amendments to the accelerated filer and large accelerated filer definitions in Exchange Act Rule 12b-2. The SEC believes that the amendments will more...more
The amendments will become effective on January 4, 2021, with earlier compliance permitted. The amendments focus on providing material financial and non-financial information regarding guarantees and other credit...more
The U.K. Prudential Regulatory Authority has published a Policy Statement, revised reporting rules and a revised Supervisory Statement on the PRA's approach to supervising liquidity and funding risks (SS 25/15). The changes...more
On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more