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28 Aug 2023, 5:40 pm
It was noted that FDA’s digital health inbox (digitalhealth@fda.hhs.gov), managed by the Digital Health Center of Excellence, could be used to get questions answered on the regulatory status of a DHT used in a clinical trial. [read post]
28 Aug 2023, 8:50 am
On the surface, September appears to have few scheduled regulatory filing dates and deadlines. [read post]
27 Aug 2023, 9:05 pm
The effect of these considerations is to lessen substantially the likelihood that the proposed changes to the HSR premerger notification process will survive judicial review.The post Premerger Notification Proposal Faces a Rocky Path first appeared on The Regulatory Review. [read post]
27 Aug 2023, 9:04 pm
first appeared on The Regulatory Review. [read post]
27 Aug 2023, 7:49 pm
The White Law Group reviews the regulatory history of Western International Securities. [read post]
26 Aug 2023, 9:05 pm
The Regulatory Review is pleased to share the following exchange with Coglianese, adapted from an interview that appeared previously in Regulatory Focus. [read post]
26 Aug 2023, 11:30 am
The organization points to the FDA’s decision to grant CTP-543 expedited review status as evidence of the long-felt, unmet need for treatment for AA patients, as well as positive results in completed Phase 3 clinical trials. [read post]
26 Aug 2023, 8:52 am
Although the SEC ultimately decided to abandon some of the most onerous regulatory burdens originally proposed last year, the new requirements are still significant, and investment advisers will need to carefully review the Final Rule to ensure such advisers are in compliance. [read post]
26 Aug 2023, 4:58 am
Trying to rely on generic templates or outdated agreements won’t cut it given China’s complex and shifting regulatory landscape. 2. [read post]
25 Aug 2023, 9:15 pm
first appeared on The Regulatory Review. [read post]
25 Aug 2023, 11:54 am
FERC will still need to review and accept the ISOs/RTOs’ tariff revisions before they become effective. [read post]
25 Aug 2023, 11:47 am
The White Law Group reviews the regulatory history of Woodbury Financial Services. [read post]
25 Aug 2023, 9:35 am
Providers must certify implementation of a Compliance Program satisfying the regulatory requirements upon enrollment and annually thereafter. [read post]
25 Aug 2023, 7:02 am
Legal and Regulatory Developments SPOTLIGHT: New Jersey Limits Card Surcharging to Merchants’ Processing FeesDigital Transactions News – August 22, 2023 New Jersey has implemented a law that prohibits merchants in the state from profiting from credit card surcharging and requires merchants to clearly disclose any surcharges to consumers. [read post]
25 Aug 2023, 1:29 am
There was no error in an inter partes review decision finding obviousness in a communication system patent because the board properly relied on materials in the record in its claim construction and obviousness analysis. [read post]
24 Aug 2023, 9:05 pm
The post Week in Review first appeared on The Regulatory Review. [read post]
24 Aug 2023, 6:42 pm
Valentine, who have been named to the “Best Lawyers: Ones to Watch” list for Administrative/Regulatory Law, Health Care Law, and Health Care Law, respectively. [read post]
24 Aug 2023, 11:18 am
In review of derivative settlements from 2019 forward, including Tesla which settled in July 2023, at least 11 lawsuits have settled for amounts in excess of $100 million. [read post]
24 Aug 2023, 10:37 am
I confess not yet to have read the new regulations, relying for the above upon review of several lawyerly sources. [read post]
24 Aug 2023, 8:00 am
These cases often require a meticulous review of all the evidence, careful consideration of liability, and extensive communication with various parties. [read post]
