The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...
The government has confirmed its intention to establish eight new Freeports in Solent, East Midlands Airport, Felixstowe & Harwich, Humber, Liverpool City Region, Plymouth & South Devon, Teesside and Thames. In our latest Freeport bitesize briefing, we look at some of the potential commercial contracts and supply chain opportunities for businesses looking to operate in these Freeports. There are generous customs and taxation benefits within Freeport sites ...
To boost the economy post-Brexit the government is committed to establishing up to 10 freeports across the UK. In our latest freeport bitesize article, we look at some of the planning implications of which bidders and bid participants should be aware. Back in August 2019 the UK Government announced plans to create ten new freeports that would be free of “unnecessary checks and paperwork, and include customs and tax benefits” ...
The Investment Coordinating Board (Badan Koordinasi Penanaman Modal – “BKPM”) recently issued Regulation No. 5 of 2019 (“Reg No. 5/2019”) which came into effect on 29 July 2019. Reg No. 5/2019 amends BKPM Regulation No. 6 of 2018 on the Guidelines and Procedures for Licenses and Investment Facilities (“Reg No ...
Overview On 1 April 2020, the Investment Coordinating Board (Badan Koordinasi Penanaman Modal – “BKPM”) issued BKPM Regulation No. 1 of 2020 on Guidelines on the Provision of Integrated Electronic Business Licensing Services (“BKPM Reg. 1/2020”).This regulation was issued to improve and streamline the licensing services provided through the Online Single Submission (“OSS”) System, to implement Article 94 (1) of Government Regulation No ...
Last week, 49 state attorneys general announced a $49.5 million settlement with Blackbaud, Inc. (Blackbaud) over the software company’s data-security practices and its response to a breach in 2020 that exposed the personal information of millions of individuals. Blackbaud provides software solutions to nonprofit organizations, including charities, schools and healthcare agencies, to help them connect with donors and manage data about their constituencies ...
On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines ...
During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
Kindly note that Decree No. 221, of the Ministry of the Interior and Public Security, was published today, extending the validity of Supreme Decree No. 102, of 2020, of the Ministry of the Interior and Public Security, which provides for the temporary closure of places authorized for the entry and exit of foreigners, due to public health emergency of international importance given the outbreak of the new Coronavirus (2019-NCOV) , until September 30, 2021 ...
California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...
It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
The Brazilian industry appears to be fully recovered from the world crisis of 2008, at least as regards Intellectual Property aspects. According to a recent official announcement made by the Brazilian Trademark Office, the number of trademark filings in Brazil raised considerably in 2010, from an estimate 111.724 applications in 2009 to a total of 129.620, which corresponds to a 16% growth ...
It seems to have avoided the worst effects of the 2009 financial crisis that shook much of the developed world, as domestic demand, government stimulus and rising commodity prices helped pull the economy out of recession faster than most countries. Indeed, the good economic momentum that catapulted Brazil forward over the past 10 years has helped 30% of the population to rise out of poverty and become consumers of products and services ...
As published in international media, Brazil is still facing economic problems related, for example, to economic growth rate and unemployment. However, Brazil remains a country where investment opportunities continue to exist. Brazil has the advantage of having a large internal market due to the size of its population and of being well positioned geographically in South America, so the country can be a platform for the export of products to other countries in the region ...
The Brazilian Secretariat of Foreign Trade, of the Ministry of Economy, published Notice nº 32/2021, initiating public consultations on the negotiations of Free Trade Agreements between Mercosur and Vietnam and Mercosur and Indonesia ...
On November 25, 2020, the Brazilian Senate approved Bill of Law No 4,458/2020 ("BL 4458"), which amends Law No 11,101/2005 ("BBL"), to update the legislation regarding the judicial reorganization, pre-packaged reorganization and bankruptcy liquidation of businessmen and companies. BL 4458, which provisions have already been approved by the House of Representatives, will now be sanctioned by the President ...
The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
On 23 April 2020, the Municipal Court in Prague issued a judgment upholding the petition for annulment of certain measures of the Ministry of Health issued in connection with the COVID-19 pandemic. With effect from 27 April 2020, the Court annulled two extraordinary measures of the Ministry of Health of 17 April 2020 and 26 March 2020 on the restriction of retail sales and two extraordinary measures of the Ministry of Health of 15 April 2020 and 23 3 ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...
