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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | POM Wonderful Appeals FTC Decision and Order but Does not Request a Stay
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 19, 2013, previously published on March 18, 2013 As we previously reported in January 2013, the Federal Trade Commission (“FTC”) determined that POM Wonderful, LLC’s advertising for its products violated the FTC Act and issued a cease and desist order restraining POM’s future advertising.
| | FDA Releases Revised Draft Guidance for “Formal Dispute Resolution: Appeals Above the Division Level”
Alexander J. Varond; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 15, 2013, previously published on March 15, 2013 On March 12, 2013, FDA released a draft version of a revision to the February 2000 final guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level.” We refer to the draft version as “Revision 1.” Revision 1 retains the original title and many of the...
| | KV Says “Heckler/Chaney Defense” is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 15, 2013, previously published on March 13, 2013 Briefing is underway in K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug...
| | FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER Case
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 13, 2013, previously published on March 12, 2013 We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the U.S. District Court for...
| | Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements?
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 13, 2013, previously published on March 12, 2013 With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management. Some of these apps are developed for and implemented by...
| | Forty-Eight State and Territorial Attorneys General Call for Tamper-Resistant Versions of Generic Prescription Pain Killers
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 12, 2013, previously published on March 11, 2013 The National Association of Attorneys General (“NAAG”) today sent a letter to the U.S. Food and Drug Administration’s Margaret Hamburg urging the Agency to adopt standards requiring manufacturers and marketers of generic prescription opioids to develop tamper-resistant versions of...
| | FDA Declines to Lower its Action Level for Mercury in Fish
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 12, 2013, previously published on March 10, 2013 FDA recently denied a citizen petition (Docket No. FDA-2011-P-0484) that asked the agency to take numerous actions with respect to mercury in commercial fish. In part, the petition asked FDA to establish an action level, regulatory limit, or tolerance of 0.5 ppm (the current action level is 1.0...
| | CDRH Issues Joint FDA/FTC Promotion and Advertising Untitled “Email” to On-line Distributors; Uses Unprecedented Approach to Warn of Possible Criminal Prosecution
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 12, 2013, previously published on March 7, 2013 On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of...
| | Prelude to a Mandatory Food Recall - and Suspension of Registration?
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 11, 2013, previously published on March 5, 2013 The Notification of Opportunity to Initiate a Voluntary Recall that FDA recently issued to a pet treat manufacturer gives a good indication of the type of evidence and circumstances that can prompt the agency to exercise its new mandatory recall authority. Before mandating a recall under FDCA...
| | Medical Device Recall or Product Enhancement? FDA’s New Draft Guidance Should Be Recalled for Significant Repairs
Hyman Phelps McNamara P.C.;
Legal Alert/Article March 11, 2013, previously published on February 28, 2013 FDA has just issued a draft guidance document titled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket No. FDA-2013-D-0114) intended to clarify how to distinguish product “corrections” from product...
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