Category:Uncategorized
Is Real ID IDeal?
By May 3, 2023, U.S travelers must be Real ID compliant to board domestic flights, enter nuclear facilities, visit military bases, and gain access to certain federal facilities. The implementation of the Real ID comes eighteen years after Congress passed the Real ID Act and ten years after the Department of Homeland Security (DHS) issued an enforcement plan for compliance with Real ID standards. Although U.S travelers have a little more than a year to comply with Real ID requirements, compliance may be difficult in light of the Real ID’s history and complications.
FDA-USPTO Collaboration Offers Insight on the Future of Generics
Following the Biden Administration’s release of the Comprehensive Plan for Addressing High Drug prices in September 2021, the Food and Drug Administration (FDA) responded by opening communication with the United States Patent and Trademark Office (USPTO). On September 10, 2021, the FDA sent a letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO seeking to further develop the FDA-USPTO relationship. The letters point out that while “bringing more drug competition to the market and addressing the high cost of medicines by improving access to affordable medications is a top priority” for HHS and FDA, the FDA is constrained by its inability to regulate the price of drugs it approves. While the FDA’s 505(b)(2) hybrid NDA and 505(j) ANDA pathway decrease the cost and time to market entry for generics, the FDA’s authority is concentrated in the pre-market review stage, with post-market authority focused on actions such as product seizure of adulterated or misbranded articles, phase-4 confirmatory trials, and other actions intended to assess the safety and efficacy of drugs.
What Will it Take to Deter Corporations from Violating Environmental Regulations?
Beverage corporation Diageo has recently been fined £1.2 million for violating environmental regulations. Diageo is a multinational corporation that owns a variety of liquor brands, including Johnnie Walker, Tanqueray, Smirnoff, Captain Morgan, Don Julio, Crown Royal, and several others. Headquartered in England, it operates all over the world, with its North American subsidiary being one of its most profitable. In violation of UK regulations, the beverage company has failed to report the environmental impacts of some of its sites for the past six years and has failed to secure permits for the relevant operations. The corporation alleges that these omissions were the result of an administrative error.
What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic
In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.
Critical Infrastructure and Cybersecurity Legislation: America’s Cybersecurity Problem
Long gone are the days when cybersecurity concerns existed solely in the domain of technology teams. Various organizations, from schools to government entities (at every level), to private companies alike have fallen prey to cyberattacks. May 2021’s Colonial Pipeline attack caused chaos and a temporary gas frenzy that brought awareness of the vulnerabilities of the technology we rely on to even the least technically minded American. Cybersecurity, and more specifically, the security of critical infrastructure immediately became an issue that the U.S. Government is taking very seriously.
First Amendment Rights and Florida’s “Don’t Say Gay” Bill
Florida’s “Don’t Say Gay” bill, which would bar Florida educators from speaking to students about LBGTQ+ topics that are not considered “age-appropriate or developmentally appropriate for students” has passed in Florida’s House and is likely to pass in the Senate as it now moves to the Republican-controlled Senate floor for a vote. The horrific piece of legislation, formally known as HB 1557, has raised questions as to whether the bill, if passed, would violate the First Amendment rights of teachers or students in public primary schools across the sunshine state.
The First Cyber War: The Threat of Russian Cyberattacks has Thrust Cybersecurity Compliance into the Spotlight
The impact of Russia’s unprovoked attack on Ukraine on February 24, 2022 has not only caused a horrific human rights crisis but has also had a dramatic effect on how the world conducts business, felt well beyond the borders of Russia and Ukraine. Warnings of an imminent Russian cyberattack on critical United States infrastructure has small and large businesses alike brushing up their cybersecurity policies to ensure they are compliant with current best practices in the likely event of a Russian cyberattack and impending federal legislation.
Why a Culture Change in the Workplace Benefits your Mentoring Program
It’s hard and expensive to find and retain good employees. With this in mind, it’s not a surprise that companies are willing to try all sorts of things to make sure their employees stick around. For example, many companies have attempted to establish corporate mentorship programs where newer employees are paired up with veterans who can show them the way. But is this the right approach? Mentoring programs typically rely on single mentor-mentee matches and formal hierarchical pairings. Even if you can implement the best mentoring program, it is unlikely to achieve its intended result when the surrounding workplace is competitive and individualistic. For mentorship programs to have a real effect on the workplace, it seems that we all must take a step back and realize that real mentorship starts with company culture, not formal programs.
The Economic War Against Russia: Sanctions, Sanctions and More Sanctions
As the pace of Russia’s incursion into neighboring Ukraine escalated three weeks ago, starting with a massing of troops on Ukraine’s eastern Donbas border and expanding quickly into a full-fledged military invasion, so too did the response of the United States and its Western allies. Initially, the Biden Administration proceeded cautiously, deciding against levying its harshest sanctions over concerns of how they would impact European and global economies and that a stepped approach offered the best chance for de-escalation of tensions. The government began by blacklisting two major state-owned banks that are tied to the country’s defense sector and five Russian nationals with close links to the Kremlin. The U.S. and its European allies also banned the Kremlin from raising new money in the U.S. and Europe and trading new sovereign debt in U.S or European markets. In addition, Germany unilaterally halted certification of the Nord Stream 2 natural gas pipeline which was set to go ahead sometime later this year, an action applauded by the U.S. who had long argued against the project fearing that it would increase Europe’s dependence on Russian fuel.
Current Status Pending: Title IX, Deliberate Indifference, & Non-Student Offenders
With the Biden administrations new proposed Title IX regulations set to be published in April of this year, attorneys and advocates alike have been left to speculate as to what changes the Department of Education (ED) will propose. Among this speculation, is a narrower question: will ED, in their proposed Title IX regulations, finally state directly that universities can be held liable for deliberate indifference to known sexual harassment perpetrated by a non-student guest? At this point, any answer to this threshold inquiry would be speculative, but there are a few indicators that suggest the answer may be yes.