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Chambers Global Practice Guide: Life Sciences 2020
Shearn Delamore & Co., June 2020

Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012)...

COVID-19: Extension of Market Access to Life-Saving and Life-Extending Drugs - Issues Impacting the Life Sciences
YKVN LLC, June 2020

Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus...

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19
Verrill, June 2020

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines key factors and procedures that Institutional Review Boards (“IRBs”) should consider when reviewing such non-emergency requests...

Impact of Medical Device Regualtions (MDR) Postponement on Swiss Medtech Industry
Walder Wyss Ltd., June 2020

  MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020...

FDA Announces Updates to Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
Verrill, June 2020

On June 3, 2020, the US Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency”. The update contains new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. (See guidance here...

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
Verrill, June 2020

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. This follows a prior update released by FDA on May 14, 2020, also described below...

Tech Versus Virus: Remote Diagnostics
Wardynski & Partners, June 2020

This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE...

Expanded Physician Payments Sunshine Act Reporting Coming Soon
Dinsmore & Shohl LLP, June 2020

The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes...

Natural Products and Pharmaceutical Innovations: What are the Patent Options?
Lavery Lawyers, May 2020

Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them...

Insurance Recovery During the COVID-19 Pandemic: Navigating Your Policy's Microbe and Pollution Exclusions
Haynes and Boone, LLP, May 2020

As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions...

Pharmaceutical Industry: It is Time to Check the Structure of Doing Business in Russia
ALRUD Law Firm, May 2020

In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products...

Modification of Decree N 466, of 1984, of the Ministry of Health, Which Approves the Regulation in the Matter of Electronic Commerce of Medicines
Carey, May 2020

On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means...

Provisions are Established to Improve and Optimize the Execution of Public Investments
Rodrigo, Elias & Medrano Abogados, May 2020

Today, May 10, Legislative Decree No. 1486 that establishes new provisions, and modifies and/or expands various regulations for the effective execution of investments by public entities has been published...

Coronavirus: Exceptional Regime for MDs and PPE
PLMJ, April 2020

The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it...

New Biosecurity Protocols for Specific Industries
Brigard Urrutia, April 2020

The Ministry of Health and Social Protection issued Resolutions 677, 679 and 681 adopting the biosecurity protocols for the control and management of COVID-19 risk in the transportation, transportation infrastructure and games of luck and chance sectors. These protocols are complementary to the general biosecurity protocol adopted through Resolution 666 of 2020 and to other measures implemented by corresponding companies...

Argentina: The Life Sciences Law Review - Edition 8
Beccar Varela, April 2020

The pharmaceutical industry continues to be a highly regulated sector that has a very important presence in Argentina. Its financial results are highly affected by the influence of agreements entered into with social security organizations – mainly the social security organization that covers retired people – and private health insurance companies...

The "Preventing Essential Medical Device Shortages Act of 2020": COVID-19 Side Effect that Could Permanently Harm Medical Device Manufacturers
Spilman Thomas & Battle, PLLC, April 2020

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the world struggles to adjust to the new reality of social distancing and self-quarantining...

Invima will Prioritize Procedure of Medicines that Treat COVID-19
Brigard Urrutia, April 2020

INVIMA will prioritize the procedures for pharmaceutical products identified as essential for the treatment of symptoms and complications of COVID-19...

Life Sciences Alert
Carey, April 2020

On April 15th, Exempt Resolution No. 258, that determines certain maximum prices in accordance with the abilities granted to the Ministry of Health by Decree No. 4/2020, was published in the Official Gazette...

FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
Verrill, April 2020

On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and answers to the guidance’s appendix. To learn more about the FDA’s guidance, please see our prior alerts here and here...

OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency
Verrill, April 2020

The U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) issued guidance, dated April 8, 2020, on the application of Common Rule requirements to research being conducted during the COVID-19 public health emergency...

What Texas Licensed Healthcare Facilities Need to Know About Resuming Nonessential Surgeries
Haynes and Boone, LLP, April 2020

We recently discussed how the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) allocates $100 billion to the Public Health and Social Service Emergency Fund, to be distributed as relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response (“Provider Relief Fund”)...

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...

 

 

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