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HTMLCOPPA Update: FTC Provides More Flexibility on Obtaining Verifiable Parental Consent
Julia M. Siripurapu; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 23, 2014, previously published on July 22, 2014
Some clarification and a bit more flexibility was forthcoming late last week from the Federal Trade Commission to help ease compliance with the “new” COPPA.

 

HTMLFDA Gives Guidance on Compounding for Human Use
Duane Morris LLP;
Legal Alert/Article
July 23, 2014, previously published on July 14, 2014
In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use.

 

HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 

HTMLFDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

 

HTMLFTC Rule Targeting Pharma Licenses Is Upheld by Federal Judge
Jordana Goodman; Sunstein Kann Murphy Timbers LLP;
Legal Alert/Article
July 21, 2014, previously published on June 2014
Last November, the Federal Trade Commission (“FTC”) announced a rule requiring advance notice of proposed exclusive patent license agreements in the pharmaceutical industry that exceed $75.9 million in value. Upon receipt of such a notice, the FTC or the Justice Department may then...

 

HTMLFDA Hosts Webinar Addressing Social Media Draft Guidance
Elizabeth H. Kim, Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
July 21, 2014, previously published on July 2014
The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director of the Office of Prescription Drug Promotion and the Center for Drug...

 

HTMLBacklash Over Facebook Timeline Experiment Serves as a Reminder: User Expectations Still Trump Fine Print
Jake Romero; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 18, 2014, previously published on July 9, 2014
If you are one of the approximately 1.3 billion people who use Facebook, you’ve likely experienced the phenomenon where a single event (like Luiz Suarez biting that Italian guy or pretty much anything involving TSA) manages to raise the ire of a large number of your Facebook friends, causing...

 

Adobe PDFThe Use of Botulinum Toxin Products in Cosmetic Applications - What’s the Litigation Risk?
Donna Marie Baloy; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
July 17, 2014, previously published on June 2014
Botulinum toxin products such as Botox® and Dysport® are used cosmetically for temporary improvement in the appearance of glabellar lines (“frown lines”) and lateral canthal lines (“crow’s feet”) in adults. Essentially, these products employ a neurotoxin,...

 

HTMLHow to Market Alcohol Beverages Legally Using Social Media
Elizabeth A. DeConti; GrayRobinson, P.A.;
Legal Alert/Article
July 17, 2014, previously published on July 15, 2014
Restaurants and bars are marketing food and beverage items using social media more than ever before. Brands use social media sites such as Twitter to engage consumers and generate conversation, and companies make offers to consumers on Facebook and Foursquare to promote brand loyalty. These offers...

 


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