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Documents on Antitrust & Trade Regulation, Pharmaceuticals, Health Care
 

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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 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...

 

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...

 

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...

 

HTMLThe Affordable Care Act is Not a Free Pass for Anti-Competitive Mergers
McDonald Hopkins LLC;
Legal Alert/Article
July 18, 2014, previously published on July 9, 2014
While the Affordable Care Act (ACA) incentivizes mergers of hospitals, physician groups, and other providers and facilities, the FTC is scrutinizing mergers that would leave few local healthcare options for patients seeking care close to home in an effort to ensure competition is preserved and...

 

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,...

 

Adobe PDFFDA Promises Guidance on Lawful Off-Label Promotion
Michael F. Buchanan, William F. Cavanaugh, Joshua A. Goldberg, Erik Haas, Daniel S. Ruzumna; Patterson Belknap Webb & Tyler LLP;
Legal Alert/Article
July 17, 2014, previously published on June 2014
Earlier this month, the U.S. Food and Drug Administration (the “FDA”) announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The healthcare industry has heralded this announcement as a...

 

HTMLPersonalized Medicine Today: PMC Issues Fourth State of the Industry Report
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
July 10, 2014, previously published on July 5, 2014
Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the understanding and adoption of personalized medicine concepts, services and products,...

 

HTMLFDA Issues Draft Guidance for Identification and Notification of Suspect Products
Duane Morris LLP;
Legal Alert/Article
July 8, 2014, previously published on June 24, 2014
As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug...

 


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