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 ...
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 ...
By means of Ordinary Resolution No. 675/2020 dated July 8th, 2020 (“Ordinary 675”), the Ministry of Energy established the criteria of the requests of Unique Collective Permits applicable to companies with power generation businesses in the context of the transit instructions issued by the sanitary authority due to the COVID-19 outbreak ...
The European Commission (“EC”) is collecting data and feedback from stakeholders about the European Union’s (“EU”) current rules on packaging and packaging waste. Based on these insights, it will propose an amendment to the current rules that aim to ensure a properly functioning market for packaging recycling and diminishing packaging waste ...
The State Water Resources Control Board (“SWRCB”) released a draft of its General Waste Discharge Requirements for Winery Process Water (“Draft WDR”) on July 3, 2020 for public comment. Comments will be accepted by the SWRCB until August 5, 2020. California wineries should review the Draft Order carefully to determine whether they will be subject to its requirements and, if so, how it will impact their operations ...
July 10, 2020 By: John Epperson The State Water Resources Control Board (“SWRCB”) released a draft of its General Waste Discharge Requirements for Winery Process Water (“Draft WDR”) on July 3, 2020 for public comment. Comments will be accepted by the SWRCB until August 5, 2020. California wineries should review the Draft Order carefully to determine whether they will be subject to its requirements and, if so, how it will impact their operations ...
On July 4, Board of Directors Resolution No. 00010-2020-OEFA/CD adopted the Regulation of the Electronic Box System of the Agency for Environmental Assessment and Enforcement (OEFA), regulating, among other aspects, the following: Mandatory use of the electronic box system to take notice of administrative acts and proceedings issued by the OEFA ...
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 ...
Key Points The Third Appellate District in Stanford Vina Ranch Irrigation Co. v. State found that the State Board could promulgate emergency drought regulations and issue curtailment orders necessary to protect threatened fish ...
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 ...
Due to the reduction to the minimum necessary staff that works in mining operations and, consequently, to the reduction of their capacity to react in the event of incidents or operational accidents,a guide for preparing contingency plans with measures to prevent these risks was approved. (Guide: Exempt Resolution No ...
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) ...
Key Points The third Golden Door iteration resulted in a common refrain: San Diego County has not yet reached the high bar for greenhouse gas mitigation (GHG) measures under CEQA Enforceability is a significant component of a CEQA compliant GHG mitigation measure In a nod to the recently approved Newhall Ranch plan, the Court of Appeal outlined the contours of acceptable carbon offset programs, both within and outside California In Golden Door Properties, LLC, v ...
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 ...
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 ...
The National Energy Commission (“NEC”) issued on May 29, 2020 the Exempt Resolution No. 176 (“NEC ER 176”) that determines the scope on the exclusive business purpose and separate accountings of energy distribution companies, for the provision of the energy distribution public service according to what was set in Law No. 21,194. The NEC ER 176 was published in the Official Gazette on June 9, 2020 ...
On June 11, 2020, Resolution No. 29/2020 (“RES 29”) of the Chilean Economic Development Agency (“CORFO”), which approved the regulations that will govern the “Green Credit” program, was published in the Official Gazette. The RES 29 aims to endorse the investment in renewable energy projects during the economic contingency arising post Covid-19. (https://www.corfo.cl/sites/cpp/sala_de_prensa/nacional/10_06_2020_corfo_crea_credito_verde) ...
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 ...
Incorporating climate reporting into new, post-COVID-19, strategies will not only help achieve net zero targets but early adopters will be at the forefront of gaining valuable expertise, market resilience and better returns. There has been much discussion about the economic model for the global effects of COVID-19 and for our transition out the other side ...
The purpose of this special report (the “Report”) is to inform the legal considerations and initial impacts that may affect the operation of a business as a result of the state of emergency for fourteen (14) days from March 16, 2020 (the “State of Emergency”) declared through Supreme Decree No ...
"Earnings for North American coal miners may plunge by more than half this year as the coronavirus pandemic makes a weak market even worse, according to Moody’s Investors Service." Why this is important: The COVID-19 outbreak continues to wreak havoc with U.S. coal companies as the outbreak has exacerbated an already weak coal market. Moody’s Investors Service has just announced it expects U.S. coal production to drop 25 percent this year ...
On May 29th, 2020 the Energy Regulatory Commission (“ CRE ”) published in the Federal Official Gazette an administrative resolution declaring the extension of the suspension of all terms and proceedings before such authority from June 01st, 2020 until the sanitary authorities determine that there are no epidemiologic risks related to the gradual, careful and organized opening of the federal public administration activities ...
