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HTMLCDER Director Woodcock Says Agency Will Focus on Filling Vacancies, Negotiating User Fees in 2016
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
With a $1.2 billion budget in 2016, the Center for Drug Evaluation and Research will focus on filling hundreds of vacancies, renegotiating user fees and progressing on labeling initiatives.

 

HTMLDOJ Recoveries Reach $3.5 Billion in FY2015 as Qui Tam Lawsuits Continue to Grow
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
For the fourth year in a row, the Department of Justice achieved more than $3.5 billion in settlements and judgments related to fraud and false claims, bringing the total secured from the False Claims Act to $26.4 billion since 2009. The pharmaceutical industry continues to contribute to DOJ...

 

HTMLPacira Secures Expanded Marketing for Painkiller Medication as FDA Agrees to Settle Lawsuit, Revoke Warning Letter
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
January 8, 2016, previously published on December 2015
The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses, as the Food and Drug Administration agreed to allow Pacira expanded marketing for its painkiller drug. The FDA settled a suit in which Pacira alleged the agency had overstepped its bounds by...

 

HTMLFDA Publishes Three Major FSMA Final Rules
Edgar J. Asebey, Jonathan Berman, Colleen Heisey; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
On November 13, 2015, the U.S. Food and Drug Administration ("FDA") published the three major rules affecting the food industry that it will adopt in 2015. These include final rules on Foreign Supplier Verification Programs ("FSVP"), Accredited Third-Party Certification, and...

 

HTMLCMS Final Rule Includes Revisions to Stark Law
Jessica Bechtel; Taft Stettinius & Hollister LLP;
Legal Alert/Article
November 27, 2015, previously published on November 12, 2015
On Oct. 30, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final Medicare physician fee schedule rule that adds two new exceptions and clarifies certain terminology and requirements of the federal physician self-referral law (the “Stark Law”). This final rule with...

 

HTMLSenate Committee Passes Bill that Redefines Marketing Exclusivity Period to Allow for DEA Scheduling
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 13, 2015, previously published on October 2015
The Senate HELP Committee unanimously passed a bill that would push back when the marketing exclusivity period begins for an FDA-approved drug, and proposes measures that require the DEA clearance process to be timelier.

 

HTMLIs Your Website ADA-Compliant? Does It Need to Be?
Ed Chansky, Robert S. Fine, Erica Okerberg; Greenberg Traurig, LLP;
Legal Alert/Article
November 10, 2015, previously published on November 5, 2015
Title III of the Americans with Disabilities Act (ADA) requires any “place of public accommodation” to be accessible to persons with disabilities. The ADA does not directly define “place of public accommodation.” Instead, it sets forth a long list of examples, such as...

 

HTMLCDRH Looks to Keep Pace with New Technology, Bolster Patient Safety with 2016 Regulatory Science Priorities
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The regulatory science priorities for FY2016 focus on the integration of new technology, including “Big Data,” into the regulatory decision-making process, with a particular emphasis on patient safety and experience. The priorities reflect a more patient-centric approach to...

 

HTMLFDA Releases Draft ICH Guidance with Aim to Improve Pharmaceutical Benefit-Risk Assessments
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Ocotber 2015
The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory submissions. The guidance doesn’t call for a particular approach, but specifies what elements should be included in submissions.

 

HTMLFDA Draft Guidance Outlines Appropriate Labeling for Injectable Drug Doses
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
November 10, 2015, previously published on Scott Liebman
The FDA released draft guidance on how to label injectable drugs for their appropriate doses, offering a new definition of single- and multiple-dose containers and replacing the term “single-use” with “single-patient-use.” Sponsors are being tasked with updating their labels...

 


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