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HTMLFDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
Duane Morris LLP;
Legal Alert/Article
February 26, 2015, previously published on December 9, 2014
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

 

HTMLFDA Proposes Three Studies on Direct-To-Consumer Prescription Drug Ads in a Bid to Better Understand the Impact of Ad Exposure Frequency, Spousal Influence and Risk Understanding
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The agency announced three proposed studies on how people view direct-to-consumer advertising, as it continues to assess factors that influence assessments of risks and benefits in a bid to ensure its regulations adequately protect public health.

 

HTMLOffice of Inspector General’s 2015 Work Plan Shows Agency Will Examine Medical Device Security, FDA’s Regulation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The Department of Health and Human Services’ watchdog agency released a 2015 work plan that calls for federal auditors to assess medical device cybersecurity amid intensifying scrutiny in the area, as well as areas that may be in need of some revamping by the FDA.

 

HTMLThe Department of Health and Human Services Proposes Tougher Reporting Rules in a Bid to Increase Clinical Trial Transparency
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The DHHS is seeking to expand the scope of information on clinical trials that must be submitted to the NIH’s online data set of experiments in the midst of ongoing concerns that too many trial results are withheld.

 

HTMLIn An Unusual Move, The FDA Takes Issue With The Accuracy Of Sciecure’s Studies In A Warning Letter Over Sales Promotion Material For The Company’s Sleeping Pill
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
In addition to criticizing the pharmaceutical company for leaving out risk information from its sales materials and making unsupported superiority claims, the regulator unusually disputed the accuracy of the sources Sciecure used to bolster its assertions.

 

HTMLMedical Bills Not Paid For Treatment/Therapy Given In India Proper As Practitioners Not Licensed In PA, Services Not Provided Under Supervision Of Licensed Health Care Practitioner, And Medical Certificates Did Not Comply With Requirements Of The Act.
Marshall Dennehey Warner Coleman Goggin P.C.;
Legal Alert/Article
February 19, 2015, previously published on January 6, 2015
Rachel Babu v. WCAB (Temple Continuing Center); 166 C.D. 2014; filed September 15, 2014; Senior Judge Colins The claimant was receiving indemnity benefits for a February 2000 work injury. In an unreported opinion, the Commonwealth Court affirmed the disallowance of Ayurvedic medical treatment...

 

HTMLPTAB Denies Request to Use Covered Business Method Review for Orange Book-Listed Patents
Jennifer L. Blackburn Ph. D., Leslie T. Grab Ph. D., Tina W. McKeon; Kilpatrick Townsend Stockton LLP;
Legal Alert/Article
February 6, 2015, previously published on January 16, 2015
The Patent Trial and Appeals Board (PTAB) denied the request to review four Orange Book-listed patents owned by Jazz Pharmaceuticals, Inc. under the covered business method (CBM) review procedure. The CBM petitions filed by Amneal Pharmaceuticals, Par Pharmaceutical, and Roxane Laboratories...

 

HTMLNew Patent Eligibility Guidance: USPTO Tones Down the Rhetoric
Jana Nelson, William L. Warren; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
February 6, 2015, previously published on December 18, 2014
On December 15, 2014, the U.S. Patent and Trademark Office issued its long-awaited Interim Guidance on Patent Subject Matter Eligibility (published in the Federal Register on December 16, link here: [(79 Fed. Reg. 74618)]). The Guidance supersedes the guidelines for determining patent eligibility...

 

HTMLNinth Circuit Clarifies Scope of Mass Action Federal Jurisdiction and Removal
Karin Bohmholdt, Benjamin S. Kurtz, Ginger Pigott; Greenberg Traurig, LLP;
Legal Alert/Article
January 23, 2015, previously published on November 26, 2014
In Corber v. Xanodyne Pharm., Inc., and Romo v. Teva Pharmaceuticals USA, Inc., &under;&under; F.3d &under;&under; (Case No. 13-56306 and 13-56310), 2014 WL 6436154 (9th Cir. Nov. 18, 2014), the Ninth Circuit, sitting en banc, held that a petition to coordinate multiple actions under California...

 

HTMLFDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci, Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article
December 10, 2014, previously published on November 17, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...

 


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