FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
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 ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
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The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
Order 3547-A/2020 of the Office of the Minister for the Environment and Climate Action was published on 22 March 2020 and it went into force at midnight the next day. This Order creates the rules that give effect to the declaration of a state of emergency in Portugal made by Decree of the President of the Republic 14-A/2020 of 18 March ...
Households and businesses across the country continue to take safety precautions in response to the COVID-19 pandemic. At the same time, the federal government is preparing an unprecedented federal response to the health, safety and economic challenges. In the coming weeks, we expect a wide variety of private businesses to partner with federal agencies and receive funds to address the health crisis ...
Federal authorities have recently issued a large number of new policies, guidance, etc., in response to the coronavirus pandemic. These include the following: Flexibility in Submitting Required Signatures on Applications The USCIS has announced it will accept application forms with reproduced original signatures ...
In the midst of the coronavirus outbreak, the Centers for Medicare & Medicaid Services (CMS) has taken steps to make healthcare services more accessible through telehealth, particularly for those who are at high-risk of complications from the virus. CMS and commercial payors have opened a viable path for healthcare providers to continue to provide care to high risk patients and other patients and receive reimbursement for services to current and new patients ...
As Democrats and Republicans continue to negotiate the terms and conditions of a “Phase 3” COVID-19 bill, the implementation of a large-scale expansion of the Small Business Administration (“SBA”) Section 7(a) Loan Program appears to have widespread bipartisan support and should pass in some form in the next few days. The existing 7(a) Program currently operates to provide access to capital to small businesses that might not otherwise be eligible for bank loans ...
Since the outbreak of the epidemiological crisis caused by the new coronavirus, the disease associated with it, Covid-19, has been spreading fast across the world, reaching the territory of the EU. According to the Commission, the virus might have an enormous public health impact with substantial fatal outcomes in high-risk groups and significant economic and societal disruptions ...
The COVID-19 pandemic has hit small businesses particularly hard. And, the Small Business Administration’s disaster loan program can offer many of those small businesses a lifeline. But, it can be daunting to know what relief is available (and for what purpose), who qualifies, and how to apply. This is what you need to know. The SBA has two types of disaster loan programs—one through banks and one directly from the SBA via the U.S. Treasury ...
North Carolina The Executive Order prohibits mass gatherings that bring together more than 50 persons in a single room or single space (including any indoor or outdoor space) at the same time. However, the prohibition against mass gatherings does not include airports, bus and train stations, medical facilities, shopping malls and centers, office environments, factories, grocery stores, and child care facilities ...
A trend is emerging with recently filed litigation involving the COVID-19 pandemic. Spilman attorneys are committed to providing information that allows businesses to react as quickly as possible to avert civil litigation threats or to protect your interests through litigation. Monitoring these litigation trends will allow organizations to prepare to defend against such threats in the future or to identify and pursue civil remedies when needed ...
The COVID-19 pandemic has hit small businesses particularly hard. And, the Small Business Administration’s disaster loan program can offer many of those small businesses a lifeline. But, it can be daunting to know what relief is available (and for what purpose), who qualifies, and how to apply. This is what you need to know. The SBA has two types of disaster loan programs—one through banks and one directly from the SBA via the U.S. Treasury ...
A trend is emerging with recently filed litigation involving the COVID-19 pandemic. Spilman attorneys are committed to providing information that allows businesses to react as quickly as possible to avert civil litigation threats or to protect your interests through litigation. Monitoring these litigation trends will allow organizations to prepare to defend against such threats in the future or to identify and pursue civil remedies when needed ...
Pennsylvania began enforcing Governor Tom Wolf’s order closing non-essential businesses at 8:00 a.m. today, March 23, 2020. Enforcement will be conducted by a number of state and local agencies, including the Pennsylvania Liquor Control Board, Department of Health, Department of Agriculture, and State Police ...
This afternoon, West Virginia Governor Jim Justice announced a Stay-At-Home Order that will affect all West Virginians. Once the Order takes effect at 8:00 p.m ...
The IRS has issued the several news releases in response to the COVID-19 pandemic: IRS Notice 2020-18 Tax Day now July 15. Treasury, IRS extend filing deadline and federal tax payments regardless of amount. The Treasury Department and IRS announced the federal income tax filing due date (for individual, trusts, estates, partnerships, corporations, and associations) is automatically extended from April 15, 2020, to July 15, 2020 ...
In further response to the COVID-19 pandemic, the Supreme Court of Appeals of West Virginia entered an order late Sunday night that declares a statewide judicial emergency applying to all lower courts in all 55 counties. As a result of the declaration, all non-emergency proceedings, including jury trials, are stayed through April 10, 2020. All deadlines and statutes of limitation that were set to expire between March 23 and April 10 are similarly tolled until April 11, 2020 ...
It is important for all companies to remember that a crisis, such as the current economic crisis that has arisen as a result of the Covid-19 pandemic, cannot be used as an excuse for companies to act as they please. EU and Swedish competition law, both the cartel prohibition and the prohibition on abuse of a dominant position, applies during a crisis as well ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) released an FAQ on Medicare provider enrollment relief, noting several key changes aimed at streamlining and expediting provider enrollment in light of COVID-19. Physicians and non-physician practitioners may now enroll and receive temporary billing privileges without certain fingerprint-based criminal background checks and site visits ...
