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HTMLFDA Puts out Guidance to Require Submissions in ICH’s Electronic Format for Certain Pharmaceutical Product Applications Within Two Years
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The regulator issued guidance in accordance with the FDCA that outlines Electronic Common Technical Document (eCTD) specification requirements for submissions of new drug or biological products, requiring that all submissions be done electronically and in the ICH-developed format within the next...

 

HTMLInjunction Blocks Implementation of Texas Telemedicine Regulations
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 16, 2015, previously published on June 4, 2015
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. The...

 

HTMLFDA to Consider Patient Preference Data During Decision-Making for Devices under PMA, HDE or De Novo Review
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The agency issued draft guidance on submitting patient preference information as part of PMA and HDE applications and de novo requests, as well as on incorporating the data in labeling, saying patient perspectives can be important to take into consideration when making benefit-risk determinations.

 

HTMLFDA Issues Guidance on Leveraging Adult Clinical Data to Support Marketing Approval and Labeling of Pediatric Devices
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The regulator is looking to remedy a lack of available scientific evidence to support pediatric device indications in PMA applications and HDEs by encouraging the extrapolation from existing clinical data, hoping the approach will streamline the requirements for establishing a pediatric intended...

 

HTMLA Split FTC Accepts Fix-It-First Divestiture Remedy for Cigarette Merger
Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 16, 2015, previously published on May 28, 2015
The Federal Trade Commission (“FTC”) accepted on Tuesday from Reynolds American Inc. (“Reynolds”) and Lorillard Inc. (“Lorillard”), subject to final approval, a Consent Order settling the agency’s significant competitive concerns with Reynolds’s...

 

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...

 

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 Rejects Otsuka’s Assertions of Orphan Exclusivity for Abilify, Allowing Generics to Proceed
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The impact of the FDA’s decision is that several companies will be allowed to enter the market with generic aripiprazole, although the generics must carve out the use of the drug for treating pediatric Tourette’s Disorder from their labeling and marketing while the exclusivity period...

 

HTMLFTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior
Dionne C. Lomax, Stephen M. Weiner, Nili S. Yolin; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 14, 2015, previously published on May 4, 2015
In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior. The FTC’s concern stems from the Certificate of Public Advantage (COPA)...

 

HTMLFTC Flushes McWane in a Big Eleventh Circuit Exclusive Dealing Win
Helen J. Kim, Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
May 6, 2015, previously published on April 22, 2015
The situations where exclusive dealing policies, explicit or tied to an aggressive discounting program, cross the line under the rule-of-reason remain far from clear. Because it involved appellate review of a Federal Trade Commission (“FTC” or the “Commission”) ruling...

 


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