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"Recent Developments in Federal Preemption of Pharmaceutical Drug and Medical Device Product Liability Claims"
Spilman Thomas & Battle, PLLC, March 2017

   Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act...

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...

At Long Last, the Notice of Proposed Rulemaking for the Common Rule is Here
Verrill, October 2015

For those of us who work in the clinical research field, the last two days have been quite exciting. At long last, the Notice of Proposed Rulemaking for the Common Rule is here, and the field is alive with talk of the proposed changes and the various ways in which the changes would impact the conduct of research in the U.S. To recap the events, on Wednesday, September 2, the U.S...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, October 2018

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  1. Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, July 2018

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...

Australian Life Sciences and Biotech - Key Themes and Trends
MinterEllison, July 2017

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.   Opportunities and Challenges – 6 Key Themes Three Key Opportunities 1...

Bills of Law on Sanitary Matters, filed in the context of the current situation
Carey, March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13...

Biosimilars: Draft Guidance Documents Issued by FDA
Haynes and Boone, LLP, February 2012

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...

Can a Member State in Times of Corona Crisis Prohibit a Pharmaceutical Company to Deliver Certain Products (Such as Testing Kits Or Protective Medical Gear) to other EU Countries?
ALTIUS/Tiberghien, March 2020

  With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed...

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)...

Chile accedes the Budapest Treaty
Carey, July 2011

On May 5th, 2011 Chile joined the Budapest Treaty on the International Recognition of the Deposit of microorganisms for the Purposes of Patent Procedure. In Chile, this treaty will enter into force on August 5th, 2011...

CMS Issues Guidance for Healthcare Providers Grappling with COVID-19
Haynes and Boone, LLP, March 2020

As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs...

Comments on the New Rules for the Registration of Infant Formula Milk Powder Formulas
Han Kun Law Offices, June 2016

Article 81 of the Food Safety Law of the PRC (the “Food Safety Law”), revised in 2015, stipulates that the product formulas for infant formula milk powder shall be registered with the food and drug administration under the State Council...

Conference “What Is Happening in Pharmaceutical Market?”
ALRUD Law Firm, October 2016

On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media...

Consumer Law and SERNAC's Supervisory Role Facing COVID-19 Pandemic
Carey, March 2020

Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation...

Coronavirus: Impact on the Operation of Pharmacies
PLMJ, March 2020

Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines...

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...

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...

COVID-19 Expanded Access Template
Verrill, March 2020

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug...

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...

COVID-19: FDA Clinical Trial Guidance
Verrill, March 2020

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic. In the guidance, FDA outlines important considerations for assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity...

COVID-19: Measures for the Procurement of Prescription Medicines and Other Health Products
Morgan & Morgan, March 2020

An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish)...

Decision Charts to Help You Navigate the Common Rule NPRM's Proposed Landscape of Covered Research, Exclusions, and Exemptions
Verrill, December 2015

In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep...

Decoding DOJ’s Crackdown on Genetic Testing: High-Profile Indictments and Practical Takeaways for the Cancer and Pharma Genomics Industries
Bradley Arant Boult Cummings LLP, March 2020

In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives...

Denmark Establishes National Genome Center
Plesner, June 2018

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...

 

 

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