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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.

 

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FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.

 

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.

 

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 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...

 

HTMLNanotechnology in Food: A Recipe for Controversy
David M. Governo, Sarah E. O'Leary; Governo Law Firm LLC;
Legal Alert/Article
May 13, 2015, previously published on April 28, 2015
Dunkin' Donuts recently made headlines when the company agreed to remove the nanoparticle titanium dioxide from the powdered sugar in its popular donuts. Titanium dioxide is used in powdered donuts as a whitening agent, increasing the attractiveness of Dunkin's products. Other nanoparticles such as...

 

HTMLUnited States Court of Appeals For The Fourth Circuit Denies Petition For Rehearing In Historic Appeal Against Chelsea Therapeutics
Faruqi Faruqi LLP;
Legal Alert/Article
May 7, 2015, previously published on April 13, 2015
On March 16, 2015, the United States Court of Appeals for the Fourth Circuit determined that the claims asserted against Chelsea Therapeutics International, Ltd. should be remanded for further proceedings because the claims had been erroneously dismissed by the district court:

 


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