FDA Announces Public Meeting for Responsible Innovation in Dietary Supplements Industry Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740 ...
Recent events, including the investigations into Facebook’s handling of its users’ personal data, have highlighted the realization that personal data is, in today’s world, one of the most valuable resources for any business and that businesses not only collect and store their customers’ personal data but also use and even sell it for profit ...
In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...
The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...
1525, the year in which the city of San Salvador was founded under the orders of Pedro de Alvarado, in Las Bermudas Valley, a place located between the city of Suchitoto and the city of San Pedro Perulapan. At this moment, you may probably be thinking “Las Bermudas Valley? That place does not ring a bell to me, I thought that San Salvador was founded where our current historical city center is located.” The answer is both yes and no at the same time ...
The Internal Revenue Service recently eliminated an inconsistency between the definition of “general public use” for purposes of the low-income housing tax credit (LIHTC) under §42 of the Internal Revenue Code of 1986 (the “Code”) and the definition of “general public use” for purposes of tax-exempt multifamily housing bonds under Code §142(d) ...
The Department of Health and Human Services Office of Civil Rights (OCR) Spring 2019 Cybersecurity Newsletter includes new recommendations regarding how HIPAA covered entities can prepare to defend against cybersecurity attacks such as advanced persistent threats (APTs) and zero-day vulnerabilities ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
California Business and Professions Code Section 10083.2 requires the California Department of Real Estate (DRE) to provide information regarding the status of every DRE licensee on its website, including information regarding any disciplinary actions taken by the DRE against a licensee. The purpose of these disclosures is to ensure full transparency concerning information the DRE deems to present a "credible risk" to members of the public. The issue with Section 10083 ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
On March 13, the Ninth Circuit issued its highly anticipated opinion in HomeAway.com v. City of Santa Monica, upholding the City's ordinance restricting short-term home rentals on popular websites like Airbnb.com. Background In light of the severe housing crisis currently afflicting California, concerns have arisen over the impact of short-term home rentals on the supply of long-term housing ...
No-one enters into a lease of commercial property looking for a fight, but experience has shown it is prudent for the parties to provide for what will happen if a dispute arises. It is common for commercial leases to contain provisions for alternative dispute resolution, by referring any matter to an arbitrator or expert for determination. Such clauses invariably provide that the decision of such arbitrator or expert will be "final and binding on the parties" ...
Many communities in Scotland are all too aware of the problems associated with living next to land or buildings that are lying vacant or derelict, particularlyin urban areaswhere neglected places are often a magnet for anti-social or criminal behaviour,becomingdumping grounds for rubbish,attracting vermin and generally posing a threat to the safety or health of those living or working in the vicinity ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...
San Francisco Supervisors Aaron Peskin and Rafael Mandelman introduced the "Housing Preservation and Expansion Reform Act" in December 2018, a proposed law which hopes to limit major renovations and demolitions plus limit the size of newly built or newly altered residential structures. The two sponsors believe the current process results in too many larger units and demolitions, and that there is a connection between the two ...
As of January 20th, 2019, San Francisco no longer requires a minimum number of parking spaces in new structures or new uses. This new law applies Citywide to all zoning districts. Previously, the City eliminated the parking requirement in many zoning districts in order to reduce traffic congestion, encourage alternative forms of transportation, and lower the cost to build housing ...
For a long time in Polish business practice it has been unclear whether clauses in construction work contracts that require one party to notify the other of circumstances being grounds for seeking additional remuneration are effective. Clauses of this kind can be found in contracts concluded according to FIDIC standard forms of contracts produced by the Fédération Internationale des Ingénieurs-Conseils ...
Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668") ...
The Ohio medical marijuana market saw a robust start to sales on January 16, 2019. First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...
On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...
This two-part webinar series explores the top construction court cases from 2018, to provide an understanding of the key developments in construction law and adjudication practiceand how these might affect your construction projects and disputes in 2019. 1. S&T (UK) Limited v Grove Developments [2018] EWCA Civ 2448 Grove employed S&T to design and build a new hotel at Heathrow Airport under a JCT Design and Build Contract ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
On 14 September 2018 the Ministry of Public Works and Public Housing of the Republic of Indonesia introduced Regulation of the Ministry of Public Works and Public Housing of the Republic of Indonesia Number 23/PRT/M/2018 on the Owners and Occupants’ Association of Multistoried Dwelling Units (“Regulation 23”) ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
