In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more
The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• EU approves Member State measures to support the economy
• Austria requests EU to suspend State aid rules
• Eurogroup Report on the comprehensive economic...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Proposed expansion of State aid Temporary Framework to recapitalization
• EU approves Member State measures to support the economy
Trade / Export Controls...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Guidance on allowing limited cooperation among businesses
• EU approves Member State measures to support the economy
Trade / Export Controls
• Commission...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• DG COMP COVID-19 website and mailbox for informal guidance
• Extension of State aid Temporary Framework
• Public short-term export credit insurance available...more
Competition & State Aid
• Delay of merger notifications
• State aid procedures fast-tracked
• Communication on Temporary State Aid Framework adopted
Foreign direct investment control
• Commission urges vigilance in...more
The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more
6/18/2018
/ EU ,
Incentives ,
Intellectual Property Protection ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
Top News -
FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions -
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
1/16/2018
/ Amended Regulation ,
Animal Food ,
CGMP ,
ECHA ,
EU ,
European Food Safety Authority (EFSA) ,
Farms ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Proposed Rules ,
Public Meetings ,
REACH ,
USDA ,
Wetlands
USDA Inspector General Recommends Reform of AMS Organic Program for Imports -
The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more
11/21/2017
/ Additive Manufacturing ,
APHIS ,
Draft Guidance ,
EU ,
European Food Safety Authority (EFSA) ,
Exports ,
Federal Register ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
France ,
Grain & Feed Commoditites ,
Imports ,
Interim Final Rules (IFR) ,
Lumber Industry ,
Menu-Labeling ,
Natural Products ,
Nutrition Facts Labels ,
Organic ,
Safety Training ,
Supply Chain ,
USDA
TOP NEWS -
FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule -
On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more
9/30/2017
/ Agricultural Sector ,
APHIS ,
Bioengineering ,
Crop Insurance ,
EU ,
European Commission ,
European Food Safety Authority (EFSA) ,
Farms ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Organic ,
Pesticides ,
Product Packaging ,
Regulatory Standards ,
UK Brexit ,
USDA
On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing additional time for implementation. The rules were finalized in May 2016 and...more
7/6/2017
/ Agricultural Sector ,
APHIS ,
China ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
Harmonization Rules ,
Imports ,
Menu-Labeling ,
Nutrition Facts Labels ,
Poultry Products Inspection Act (PPIA). ,
Regulatory Standards ,
Risk Assessment ,
USDA
June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more
On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more
On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more
6/30/2017
/ Canada ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Imports ,
Legislative Agendas ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OMB ,
Pharmacies ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice...more
Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more
French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research. Such research should now be referred to as "research...more
The European Food Safety Authority ("EFSA") has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material....more
On April 28, 2017, the European Commission issued Regulation 2017/752, amending Regulation 10/2011 on plastic materials and articles intended to come into contact with food...more
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more
5/19/2017
/ Amended Regulation ,
Australia ,
Dairy Farmers ,
European Commission ,
European Food Safety Authority (EFSA) ,
FDA Commissioner ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
FSVP ,
GMO ,
Italy ,
Organic ,
Pesticides ,
Senate Confirmation Hearings ,
USDA
On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and was...more
New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more
5/15/2017
/ App Developers ,
Attorney General ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
GPS ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
Mobile Medical Applications ,
OCR ,
Privacy Policy ,
State and Local Government