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HTMLBig Win for Anti-GMO Groups as Federal Judge Upholds Jackson County GMO Ban
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 18, 2015, previously published on June 2, 2015
On Friday, Federal Magistrate Judge Mark D. Clarke partially dismissed a lawsuit brought by commercial alfalfa farmers seeking to overturn a Jackson County ordinance that banned the use of GMO seed stock (“It is a county violation for any person or entity to propagate, cultivate, raise, or...

 

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...

 

HTMLFood Court Report: Consumers Can Challenge Certified Organic Products They Believe Contain Improper Ingredients
Douglas J. Behr, Melvin S. Drozen, Arthur S. Garrett, Eric P. Gotting, Leslie T. Krasny; Keller and Heckman LLP;
Legal Alert/Article
May 25, 2015, previously published on May 13, 2015
In Segedie v. The Hain Celestial Group, Inc., a trial court in the Southern District of New York held that plaintiffs had properly stated a claim of consumer fraud based on alleged misuse of the term “organic.” The court rejected the defendant’s argument that the plaintiffs’...

 

HTMLAre Cosmetics Gaining Higher Congressional and FDA Scrutiny?
Katherine Fox, Michelle Gillette; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 21, 2015, previously published on May 18, 2015
Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting. Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) seek to change that.

 

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.

 

HTMLCan You Label your Food Product as "Healthy?"
John W. Mashni; Foster, Swift, Collins & Smith, P.C.;
Legal Alert/Article
May 15, 2015, previously published on April 30, 2015
Do you sell a food product that you would like to label as “healthy?” Using the term is more complicated than it seems. One company has recently discovered how seriously the government regulates food labeling.

 

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...

 

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.

 


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