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Coronavirus Digest No. 2: Patents and Other Intellectual Property Rights
PLMJ, August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces toprepare a Digest on these issues that is continuously updated...

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
Verrill, August 2020

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory Developed Tests (“LDTs”) and eliminating the requirement for premarket review of LDTs, in the absence of notice-and-comment rulemaking...

DOJ Aims Scrutiny at Lab Testing Space During COVID-19
Bradley Arant Boult Cummings LLP, August 2020

The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers...

Coronavirus Digest No. 3: Patents and Other Intellectual Property Rights
PLMJ, August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces to prepare a Digest on these issues that is continuously updated...

FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines
Patterson Belknap Webb & Tyler LLP, July 2020

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline...

Digital Labelling of Medications
ALRUD Law Firm, July 2020

As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system...

Patenting COVID-19 Tests: Avoiding the Common Pitfalls
Bradley Arant Boult Cummings LLP, July 2020

The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available...

Use of the Corona-Warn-App in the Workplace
Heuking Kühn Lüer Wojtek, June 2020

On June 16, 2020 the German government released its Corona-Warn-App. There are some key points employers should be aware of concerning the app: NO OBLIGATION FOR EMPLOYEES TO USE THE APP ON THEIR PERSONAL SMARTPHONES An employer may be thinking about instructing its employees to install and use the Corona-Warn-App on their own devices to reduce the infection risk among its employees. That is not permitted...

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 Nº 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...

 

 

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