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
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Intellectual Property Protection ,
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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
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Animal Food ,
CGMP ,
ECHA ,
EU ,
European Food Safety Authority (EFSA) ,
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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Draft Guidance ,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 ,
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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
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
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 April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
5/12/2017
/ Biosimilars ,
EU ,
European Commission ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Standards ,
UK Brexit
On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part...more
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its 2017-2018 business plan. Of the 10 key priorities identified by the MHRA, life...more
FDA Amends Waivers to Sanitary Transportation Rule -
On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more
4/13/2017
/ Animal Food ,
Annual Reports ,
Chemicals ,
EU ,
European Food Safety Authority (EFSA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
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National Security ,
Pesticides ,
Sanitary Food Transportation Act (SFTA)