Home > Legal Library > Advanced Search > Search Results









Join Matindale-Hubbell Connected



Search Results (414)

  
Documents on Antitrust & Trade Regulation, Food & Beverage
 

View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>
Show: results per page
Sort by:
Sponsored Results

HTMLChina Regulatory Affairs: China Notifies WTO of Draft General Safety Standard for Food-Contact Materials
Yun Chen, David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
Legal Alert/Article
June 26, 2015, previously published on June 24, 2015
On May 22, 2015, China notified to the World Trade Organization (WTO) Committee on Sanitary and Phytosanitary Measures its draft Standard on the General safety requirements for food contact materials and articles for public comment. The Standard was developed by the National Health and Family...

 

HTMLFDA Makes More Electronic Submissions Mandatory
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 1, 2015, previously published on May 22, 2015
UPDATE: On May 27, 2015, FDA announced that it was granting additional time for companies to begin submitting electronic postmarketing safety reports for drugs and biologics. Although the effective date for the requirement is June 10, 2015, the Agency is delaying the compliance date until September...

 

HTMLMedical Marijuana in HUD-Assisted Properties: Update Since HUD’s January 2011 Memorandum
Angela M. Sekerka; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
May 28, 2015, previously published on May 22, 2015
The U.S. Drug Enforcement Agency (DEA) classifies marijuana as a Schedule I Controlled Substance, which recognizes no medical use. In January 2011, the U.S. Department of Housing and Urban Development (HUD) issued an often-cited memorandum entitled “Medical Use of Marijuana and Reasonable...

 

HTMLFDA Makes More Electronic Submissions Mandatory
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
May 26, 2015, previously published on May 22, 2015
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry...

 

HTMLFDA Issues Guidance Documents on How It Considers Balancing Premarket and Postmarket Data Collection During PMA Reviews in a Bid to Accelerate the Approval of New Breakthrough Devices
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator explains how it determines when it’s appropriate to increase reliance on postmarket collection to reduce the extent of premarket collection to support premarket approval, in a document integral to the CDRH’s risk-based approach to regulation and the FDA’s broader...

 

HTMLOPDP to Study The Impact of Comparative Pricing Information in DTC and Professional Prescription Ads
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The agency will investigate how prescription drug product perceptions are impacted by the inclusion of price comparison information and supplementary contextual information in advertising geared at consumers and health care professionals, amid concern that the impression remains that price is the...

 

HTMLFDA Finalizes Three Guidance Documents on Biosimilars
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Christopher M. Mikson; Jones Day;
Legal Alert/Article
May 15, 2015, previously published on May 2015
FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.

 

HTMLGuidance Explains How The FDA Will Define and Process Submissions for Changes to Risk Management Plans
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The regulator issued guidance on changes to approved risk evaluation and mitigation strategies (REMS), distinguishing “modifications” from “revisions,” and explaining how these should be submitted and how the FDA will review and act on them.

 

HTMLFDA to Conduct Study to Determine Whether Medical Device Labeling Should Be Standardized
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 14, 2015, previously published on April 2015
The study will look into whether a standard format of labeling would be beneficial to healthcare providers, as the regulator worries current labeling is too complicated and difficult to navigate.

 

HTMLChina Passes Sweeping Amendment to Food Safety Law: The Most Stringent To Date
Yun Chen, David J. Ettinger, Mark Thompson; Keller and Heckman LLP;
Legal Alert/Article
May 13, 2015
On April 25, 2015, after two rounds of comment solicitation and revision in 2013 and 2014, the Standing Committee of the National People's Congress of China passed the amended Food Safety Law (“Law”).[1] The Law, which will enter into force on October 1, 2015, is considered the most...

 


View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>