On April 6, the Food and Drug Administration (FDA) issued five warning letters chastising companies for their unapproved products related to the novel coronavirus disease 2019 (COVID-19). Two days later, the FDA issued another four warning letters for similar reasons. Two of the five warning letters issued on April 6 were issued to companies in connection with their CBD products, and one of the warning letters issued on April 8 was issued to a CBD company as well ...
On April 6, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule in the Federal Register that, among other initiatives and changes to existing policy, allows certain inpatient hospital services to be provided “under arrangements” outside of the hospital. The “March 2020 IFC” is intended to give healthcare providers increased flexibility to respond to the public health emergency created by COVID-19 ...
On 30 March 2020, the Ukrainian Parliament adopted the Law "On Amendments to Certain Legislative Acts Aimed to Ensure Additional Social and Economic Guarantees Due to the Coronavirus Disease (COVID-2019) Spread" (the Law), which introduces to the Ukrainian legislative environment new complex rules aimed at minimizing the negative impact of the spread of the COVID-19 in Ukraine. The below summary focuses on key changes introduced by the Law ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
Nursing homes have been on the front lines throughout the COVID-19 pandemic as they care for the persons most at risk. In an effort to improve safety and curb the spread of COVID-19, federal and state authorities are relaxing certain compliance obligations. Despite this regulatory latitude, nursing facilities should remain aware that federal and state agencies continue to closely monitor nursing home compliance ...
On Saturday, April 4, 2020, the Antitrust Division of the U.S. Department of Justice (“DOJ”) issued a business review letter to a number of providers of Personal Protective Equipment (“PPE”) and pharmaceutical products, stating that the DOJ “presently does not intend to challenge” their efforts to expedite and increase manufacturing, sourcing, and distribution of PPE and medications in connection with Project Airbridge ...
Below is a summary of key new measures and initiatives that have been implemented and announced by various UAE authorities since 6 April 2020 and the time of this inBrief, 6:00 p.m. on Wednesday, 8 April 2020 ...
The U.S. Department of Justice (DOJ) has issued a series of memoranda that discloses the department’s enforcement priorities and provides public guidance related to the ongoing coronavirus crisis ...
Below is a summary of key new measures, as well as clarifications on previous measures we reported on, that have been implemented by various UAE authorities since 5 April 2020 and the time of this inBrief, 6:00 p.m. on Tuesday, 7 April 2020 ...
Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...
In order to avoid the shortage of antiseptic and disinfectant products for external use, the Colombian Ministry of Health issued Resolution 520 of March 28, 2020 in order to establish new requirements for the manufacture of the above-mentioned products within the Colombian territory ...
Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions ...
Since the publication of our legal update on COVID-19 Legal Challenges for Pharmaceutical Companies on 31 March 2020, new important measures were adopted or announced on both national and EU level ...
The new measures adopted by the European Commission Last Friday, the European Commission (“Commission”) has adopted an amendment to existing State aid rules to widen the perimeter of the national measures which can be authorized based on the exceptional legal framework to cope with the current crisis. a. In particular, the Commission considered the following measures:a. More support for research and development related to the current health crisis ...
Even though the COVID-19 crisis has shuttered many government and commercial activities, the nation’s antitrust regulators are still very much open for business ...
This supplements our inBrief dated 3 April 2020, which reported on measures implemented by the UAE authorities in response to COVID-19 up to 9:00 a.m. that day. Many new measures have been introduced since then. We now report on new measures taken up to 9:00 a.m. on Monday 6 April 2020 ...
The Centers for Medicare & Medicaid Services hasrecently announced an unprecedented “Hospitals Without Walls” program to aid in the fight against COVID-19. The goal of this program is to ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites including other, non-affiliated healthcare providers and even unlicensed locations such as community centers and schools ...
On March 30, 2020, the Secretary of the Department of Health and Human Services ("Secretary") announced a blanket waiver ("Waiver") of sanctions for violations of Section 1877 of the Social Security Act, also known as the physician self-referral law or Stark law ("Stark Law") ...
With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
“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”) ...
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes $100 billion for Medicare and Medicaid-enrolled suppliers/providers that provide diagnosis, testing or care for individuals with possible/actual cases of COVID-19 ...
On April 2, President Trump moved to use the Defense Production Act of 1950 (“DPA”) to expand the authority of the Department of Homeland Security to intervene in the private sector to order and prioritize production of supplies and equipment needed to address the coronavirus pandemic ...
