The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
Last week, 49 state attorneys general announced a $49.5 million settlement with Blackbaud, Inc. (Blackbaud) over the software company’s data-security practices and its response to a breach in 2020 that exposed the personal information of millions of individuals. Blackbaud provides software solutions to nonprofit organizations, including charities, schools and healthcare agencies, to help them connect with donors and manage data about their constituencies ...
On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines ...
During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
Kindly note that Decree No. 221, of the Ministry of the Interior and Public Security, was published today, extending the validity of Supreme Decree No. 102, of 2020, of the Ministry of the Interior and Public Security, which provides for the temporary closure of places authorized for the entry and exit of foreigners, due to public health emergency of international importance given the outbreak of the new Coronavirus (2019-NCOV) , until September 30, 2021 ...
California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...
It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
This is a briefing on the following issuances as of April 19, 2020 in relation to the COVID-19 pandemic: A. Extension of Periods for the Filing and Submission of Various Documents and Payment of TaxesB. Mandatory Disclosure of Personal Information of COVID-19 Patients C. Securities and Exchange Commission (SEC) Issuances D. Bangko Sentral ng Pilipinas (BSP, the Central Bank of the Philippines) Issuances E. Insurance Commission (IC) Issuances F ...
Key Points Governor Newsom vetoed AB 339. AB 361 will continue to operate as currently construed. On October 7, 2021, Governor Newsom vetoed Assembly Bill (AB) 339 (Lee), a bill aimed at addressing Brown Act teleconferencing requirements for large public entities. AB 339 sought to add special rules for meetings of city councils or county board of supervisors that govern jurisdictions containing at least 250,000 people ...
Businesses are experiencing devastating losses due to mandated restrictions and shutdowns, as well as the cancellation of events. What’s more, no one knows how long this will continue. As a result, many businesses are considering whether their insurance might provide some relief from the losses they already have incurred, or likely will incur, due to this crisis ...
“With our nation’s health care providers on the front lines in the fight against COVID-19, dollars and cents shouldn’t be adding to their worries.” - CMS Administrator Seema Verma. During this Public Health Emergency, the Centers for Medicare & Medicaid Services (“CMS”) has expanded its accelerated and advanced payment program (“Program”) to all Medicare-enrolled providers and suppliers (“Providers”) ...
On Friday, March 27, 2020, the CARES ACT was signed into law. The Cares Act includes provisions for changing deadlines for patents, trademarks, and copyrights. For patents and trademarks, the Act permits the Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office to change the deadlines imposed by Title 35 of the United States Code, the Trademark Act, Section 18 of the Leahy-Smith America Invents Act ...
In addition to proceeds from the U.S. Small Business Administration’s (“SBA”) Payment Protection Program and the Centers for Medicare & Medicaid Services’ (“CMS”) Accelerated and Advance Payment Program, the U.S. Department of Health & Human Services (“HHS”) recently deposited $80 billion into health care providers’ bank accounts as part of its Provider Relief Fund ...
As COVID-19 cases have continued to spread across the country resulting in government-issued “shelter in place” orders, few industries have felt the impact as swiftly and deeply as the restaurant industry. Indeed, such government orders have required restaurants to shut down all onsite dining, causing a sharp decline in restaurant revenue. According to restaurant ...
As California continues to move through Stage 2 of its Resilience Roadmap, “Lower-risk workplaces,” where retail (curbside and delivery only), related logistics and manufacturing, office workplaces, limited personal services, outdoor museums, childcare, and essential businesses can now open with modifications, California employers should continue to be vigilant in assessing and complying with up to date health and safety guidance from the Occupational Safety and Health Admini
Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation ...
September 16, 2021 By: John Epperson The COVID-19 pandemic will likely to be a concern and challenge for employers for longer than anyone had hoped or anticipated. As businesses adjust to what seems to be a “new normal” it is worth a reminder that COVID-19 infection can be a recordable illness on an employer’s Occupational Safety & Health Administration (“OSHA”) 300 Injury and Illness Log. OSHA’s recording criteria under 29 CFR 1904 ...
