More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
Population growth has become the be-all and end-all for economic prosperity, but how on Earth can we cope with the extra billions of people? While “leafing” – or should I instead say “scrolling” in today’s need to sound tech savvy – through the news websites, the two subjects seemed to have captured the media’s attention: immigration and plastic ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
When a half-mile from the nearest body of water, must you obtain a federal permit when discharging treated wastewater to groundwater? According to a recent Ninth Circuit decision, the answer may be yes.[1] This alarmed many because the Clean Water Act regulates discharges to navigable waters from "point sources" like pipes or ditches ...
EPA Administrator Pruitt recently issued another policy to help streamline the New Source Review (NSR) Program. After receiving comments from many industry sources that the NSR Program should be reformed given its heavy time and cost burden, the Trump EPA has made reforming the NSR Program a priority ...
On April 12, 2018, President Trump issued a memorandum to Administrator Pruitt to promote domestic manufacturing and job creation through policies intended to streamline implementation of national ambient air quality standards (NAAQS) ...
Earlier this year, revisions to the requirements for new and existing indirect heat exchangers contained in 401 KAR 59:015 and 401 KAR 61:015 became effective. Indirect heat exchangers with a heat input capacity greater than one million Btu/hour (MMBtu/hour) are subject to either 401 KAR 59:015 (new sources) or 401 KAR 61:015 (existing sources). The classification as new or existing depends upon when the indirect heat exchanger was installed ...
The Administrative provisions that set forth the guidelines for comprehensive management of waste requiring special management in the hydrocarbons sector (the “Guidelines”) were published in Mexico’s Federal Official Gazette on May 2, 2018 and became effective the following day ...
With Administrator Scott Pruitt at its helm, cooperative federalism is the frequently recited principle underlying recent EPA enforcement efforts. As the Environmental Protection Agency’s regulatory oversight in areas like the Clean Water Act is delegated to the states, the agency is relying more upon state and local authorities to enforce the laws. There are shortcomings associated with this approach, which were raised in the recent U.S ...
It was this time last year that U.S. Environmental Protection Agency Administrator Scott Pruitt created a Superfund Task Force to “provide recommendations . . ...
Geographical indication of origin, this very peculiar form of industrial property protection, has undergone a revival phase over the past few years, thus becoming more omnipresent not only within the circles of interest, but also amongst the Serbian public at large. Although, up to this day, there are only a few dozen geographical indications of origin registered before the Serbian Intellectual Property office, for a country of little over 7 million spread over 80 ...
The first upscale exploration of oil and gas in Montenegro started in 1914, when King Nikola Petrovic approved the National Assembly's decision for oil exploration around Lake Skadar. The first well in the area of Crmnica dates back to 1922 - although it produced nothing of significance. In later researches of the Montenegrin offshore, the existence of geological structures with the potential for hiding hydrocarbon deposits was confirmed ...
Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...
The Corps Struggles to Balance Competing Constitutional and Statutory Duties Federal agencies must often balance competing policy concerns and legal requirements. This process may be difficult and fraught with intense public feedback, and frequently results in litigation. The U.S. Army Corps of Engineers (the Corps) has found itself in the hot seat over how it manages the nation’s rivers, pitting its obligations under the Endangered Species Act (ESA) against private property rights ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
Proposition 65 is a 1986 California right-to-know law requiring businesses to provide “clear and reasonable” warnings of potentially harmful exposures to chemicals appearing on the growing list maintained by California’s Office of Environmental Health Hazard Assessment (“OEHHA”) ...
As the Trump administration is pushing forward on its deregulatory agenda and, in particular, its efforts to improve the Endangered Species Act (ESA) and its implementation by the US Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (together, the Services), the Supreme Court is poised to hear a landmark case on designation of critical habitat under the ESA that could provide some guideposts for the Services’ new regulations ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
The Court of Justice of the European Union (CoJ) handed down an important judgment last week on the protection of geographical indications of spirit drinks in a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (Scotch Whisky Association (SWA) v Michael Klotz (Case C-44/17)). Facts: Mr Klotz markets a whisky under the designation ‘Glen Buchenbach’, which is produced by a distillery located in Berglen in the Buchenbach valley in Germany ...
The international trading market is currently quite favorable to commodity-producing countries such as Brazil. In recent months, the Bloomberg Commodity Index, which tracks daily the performance of main commodities, closed at US$89.49, 1.5% higher than it was at lhe end of 2017 and 6.73% higher than it was 12 months ago ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...
