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 ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
Financial Market Commission Announces a Package of Measures to Facilitate Credit Flow to Both Companies and Individuals By Diego Peralta and Diego Lasagna On March 23, 2020, the Financial Market Commission’s Council (“CMF”) approved new measures destined to grant more flexibility to the financial system, in the context of the coronavirus Covid-19 global outbreak ...
Upon the sanitary emergency triggered by COVID-19 and the consequential slowdown for commerce and the economy in general, it is likely that many companies will lack the liquidity to face payments for their creditors, suppliers, personnel, etc ...
Article 1 of Decree 466 states that the National Guarantee Fund S.A. (hereinafter "NGF") must comply with and accredit a solvency ratio, which is determined based on the technical assets that must have a direct relationship with the risk assumed in its capacity as guarantor ...
On March 22, 2020, the Federal Reserve Board, the FDIC, the National Credit Union Administration, the Office of the Comptroller of Currency, the Consumer Financial Protection Bureau and state banking regulators (collectively, the “agencies”) published an interagency statement on loan modifications and reporting for financial institutions working with customers affected by COVID-19 ...
On March 22, 2020, several federal financial institution regulatory agencies and state banking regulators issued an interagency statement encouraging all financial institutions to work constructively with borrowers impacted by the ongoing Coronavirus Disease 2019 (“COVID-19”) ...
The U.S. Small Business Administration (SBA) is an independent agency of the federal government established to provide assistance and protection in the interest of small businesses. Among its funding programs, the SBA Disaster Assistance program provides low interest loans to help businesses and homeowners to recover from declared disasters – usually for events such as hurricanes or floods ...
Co-authored by MV Credit Partners LLP As the world watches the spread of COVID-19 across all continents, global economies are reacting to the impact and trying to foresee eventualities to mitigate the inevitable loss. There are some industries that will undoubtedly be more effected than others, and as with any economic crisis this will have a knock-on effect ...
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 ...
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 ...
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 ...
As we all know by now, much of our day-to-day lives have been upended by the COVID-19 pandemic. We are being told by everyone everywhere - the CDC, the President, governors, mayors, public health officials - we need to flatten the curve of the virus' natural exponential spread by practicing social distancing and aggressive hand washing ...
No one can predict all the effects of the pandemic on the borrower/lender relationship, but some of those effects will be severe. Both parties place a high value on predictability in their dealings. A borrower must know that when it needs funds, the line of credit will be available, while a financial institution needs to have payments made and covenants met as provided in the financing documents. Its long term survival depends on it ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
In light of the rapidly evolving developments relating to COVID-19, and recognizing that issuers have an urgent need to focus on critical business decisions, the Canadian Securities Administrators (the “CSA”) have announced that they will grant temporary, blanket relief from the filing of certain documents required to be filed on or before June 1, 2020 ...
On 18 March 2020, the Financial Market Commission (“CMF”) issued general rule 435 (hereinafter “NCG No. 435”) amending general rule 273 from 2010, which, in turn, regulates the voting systems for shareholders meetings ...
Following the publication of the proposal a few days ago, on 19 March the European Commission adopted the communication introducing a new temporary legal framework for State aid measures to support the economy in the current COVID-19 outbreak1. The last time the Commission had adopted a similar temporary framework was during the global financial crisis in 2008 ...
