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What Healthcare Providers Need to Know About Receiving Payments Under the CARES Act Provider Relief Fund
Haynes and Boone, LLP, April 2020

The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), a historic $2 trillion relief package signed into law on March 27, 2020, seeks to address the economic impact of the COVID-19 pandemic on several industries...

Coronavirus: Changes to Clinical Trials
PLMJ, April 2020

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...

INVIMA's Measures until the Health Emergency Remains in Force
Brigard Urrutia, April 2020

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...

Increased Liability for Breach of Measures to Prevent the Spread of Coronavirus (COVID-19)
ALRUD Law Firm, April 2020

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...

Updated FDA COVID-19 Guidance for Conduct of Clinical Trials
Verrill, April 2020

On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding a series of questions and answers (“Q&A”)...

Coronavirus: Impact on the Operation of Pharmacies
PLMJ, March 2020

Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines...

Q&A Regarding Procedures before the Chilean Public Health Institute and the Power to Set Prices for Certain Pharmaceutical Products, Medical Devices, Etc. is Established
Carey, March 2020

Q&A procedures before the Public Health Institute (ISP)   May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds...

Bills of Law on Sanitary Matters, filed in the context of the current situation
Carey, March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13...

Drug Exports in a Time of Pandemic
Wardynski & Partners, March 2020

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic...

Tariff Exclusions on Medical Goods Due to COVID-19 Pandemic, the Exclusion Extension Process, and Other US-China Trade Developments
Dinsmore & Shohl LLP, March 2020

The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S...

When COVID-19 Impacts Research Projects: How to Prepare and Adapt
Dinsmore & Shohl LLP, March 2020

With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home...

Consumer Law and SERNAC's Supervisory Role Facing COVID-19 Pandemic
Carey, March 2020

Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation...

FDA Increase Supplies in Response to COVID-19
Haynes and Boone, LLP, March 2020

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 COVID19 Products
Haynes and Boone, LLP, March 2020

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...

COVID-19: Measures for the Procurement of Prescription Medicines and Other Health Products
Morgan & Morgan, March 2020

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)...

FDA Revised Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
Haynes and Boone, LLP, March 2020

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...

HHS Extends PREP Act Immunity to COVID-19 Countermeasures
Haynes and Boone, LLP, March 2020

The U.S...

FDA Issues "Immediately in Effect" Guidance to Accelerate Availability of COVID-19 Diagnostic Tests
Haynes and Boone, LLP, March 2020

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...

FDA Issues Temporary Guidance on Food Supplier Verification Audit Requirement
Haynes and Boone, LLP, March 2020

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...

Health Law Vitals - COVID-19 Edition - March 2020
Haynes and Boone, LLP, March 2020

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...

Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow
Haynes and Boone, LLP, March 2020

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...

CMS Issues Guidance for Healthcare Providers Grappling with COVID-19
Haynes and Boone, LLP, March 2020

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...

COVID-19: FDA Clinical Trial Guidance
Verrill, March 2020

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic. In the guidance, FDA outlines important considerations for assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity...

Impact of The Coronavirus (COVID-19) Pandemic on Proceedings Before the Trade Mark And Design Offices
Heuking Kühn Lüer Wojtek, March 2020

The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1...

Decoding DOJ’s Crackdown on Genetic Testing: High-Profile Indictments and Practical Takeaways for the Cancer and Pharma Genomics Industries
Bradley Arant Boult Cummings LLP, March 2020

In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives...

 

 

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