FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
Key Notes FDA announces flexible approach to enforcement of Nutrition and Supplement Facts labeling requirements for small food manufacturers and manufacturers of packaging for single-ingredient sugars, in part due to the impacts of COVID-19. The FDA adopted final rules updating the Nutrition and Supplement Facts1 labeling requirements (the “Rules”) that are effective on Jan ...
On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
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 Jan. 29, 2020, OCR released a notice regarding a recent federal court ruling in the case of Ciox Health, LLC v. Azar, et al ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
On March 1st, 2015, the federal Minister of Finance, Joe Oliver, and the federal Minister of Natural Resources, Greg Rickford, announced important new measures to support Canada’s mining industry in a speech at the Prospectors and Developers Association of Canada (PDAC) 2015 Convention ...
The U.S. Department of Health and Human Services (HHS) just announced that Provider Relief Fund Program (PRF) recipients will now be required to submit reports regarding their use of these funds later than previously announced. The previous deadline was February 15, 2021. Currently, a specific new timeline was provided, but HHS is encouraging providers to register to receive updates ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program ...
In a move that indicates significant regulatory changes may be coming to deepwater operations, federal authorities are eyeing new rules curtailing venting of natural gas in the Gulf of Mexico ...
It is slowly starting to feel like distant history when civilisation's efforts to satisfy the most fundamental need for energy were focused mainly on utilising non-renewable sources. Fossil fuels, natural gas, oil, and coal have been the backbone of the industrial age's rapid development, effectively helping bring on the contemporary era of existence we are witnesses of ...
In the latest update to Kentucky’s Medical Cannabis Program (the “Program”), Governor Andy Beshear signed House Bill 829 which moved up the timeline to apply for cannabis business licenses by six months. Additionally, two emergency regulations were issued by the Program that explain how to apply for a cannabis business license ...
Feeling the heat: the draft Climate Change Bill, 2018 Earlier this year, the South African Minister of Environmental Affairs (the “Minister”) published the draft Climate Change Bill, 2018 for public comment. Since then, the Department of Environmental Affairs (“DEA”) has undertaken a road show across the country to solicit comments to the Bill and held further bilateral meetings with stakeholders earlier this year ...
On 20 March 2013, the Finnish government issued its much-awaited proposal for a new Electricity Market Act and an amended Natural Gas Market Act. It also sent to the parliament a separate supervision act. The proposal implements the European Union’s third Electricity and Natural gas Directives to the Finnish legislation. It also includes numerous nationally prepared amendments and changes ...
In the False Claims Act (FCA) case of Feinwachs v. Minnesota Hospital Association, the district court recently upheld relator David Feinwachs’ claim of work-product privilege over emails sent to his work email account. No. 11-cv-0008, 2019 U.S. Dist. LEXIS 155027 (D. Minn. Sept. 11, 2019). Feinwachs was formerly general counsel of the Minnesota Hospital Association (MHA), a trade association of Minnesota hospitals and health care systems ...
This morning FERC issued an order approving in part and rejecting in part the CAISO’s tariff filing creating a new Off-Peak Deliverability Status (“OPDS”) for interconnection customers. The proposal was driven in part by the California Public Utilities Commission’s new methodology for calculating the qualifying capacity of solar and wind resources and the shift in peak demand to a period later in the day when less solar is available ...
On May 21, 2020, the Federal Energy Regulatory Commission’s Offices of Energy Policy and Innovation and Electric Reliability jointly published and released their 2020 Summer Energy Market and Reliability Assessment. The report provides an overview of key market events and data for the nation’s ISOs/RTOs as well as a discussion on reliability in the various power regions for summer 2020. The report includes the following key items that are summarized below ...
In response to solar industry concerns that its regulations were stifling the country’s solar energy development, the Federal Energy Regulatory Commission initiated a rulemaking on January 17 to amend its regulations applicable to the interconnection of facilities of 20 MW or less to the grid ...
