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Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

China Issues Guidance Clarifying Core Tasks and Deadlines for Application of the Country’s Telemedicine System

The Chinese government has been in the process of modernizing its telemedicine law and policy and associated infrastructure for nearly 2 years now, to support broad, domestic application of telemedicine. We outline one of the...more

Privacy & Cybersecurity Newsletter: July 2016

General Data Protection Regulation Update - As reported in the April Locke Lord Privacy & Cybersecurity Newsletter, the European Parliament gave the final approval to the General Data Protection Regulation (GDPR) on...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Will the USPTO’s “Patents 4 Patients” Program Even Make It Off the "Cancer Moonshot" Launch Pad?

The White House recently announced the Cancer Moonshot Task Force, an effort to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

European General Data Protection Regulation to Apply from May 2018

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Ukraine further simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...

As we reported in our previous alert, the Cabinet of Ministers of Ukraine has recently adopted Resolution No. 312 simplifying the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...more

EU Law Making Bodies Entered into an Agreement on the New EU Medical Devices Regulations on May 25, 2016

On May 25, 2016, the European Parliament, European Council and the European Commission agreed on new rules regarding the approval and surveillance of medical devices and in vitro diagnostics for the European market. The...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada...

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – May 2016

Special Focus on “Safe Harbor 2.0,” Privacy Shield and E.U. Data Transfers: Alston & Bird’s privacy team has been closely following the development of Privacy Shield, the proposed successor to the E.U.-U.S. Safe Harbor...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Public Health Organizations Urge Congress to Reject Trans-Pacific Partnership Agreement

In a letter sent to members of Congress earlier this month, 58 public health organizations urged Congress to reject the Trans-Pacific Partnership (TPP) in its current form, stating that the coalition was "alarmed by the...more

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare...more

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