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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | The Medical Device Amendments of 1976: The Statute That Went Awry
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article June 5, 2013, previously published on June 03, 2013 The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation. In one sense, this description is absolutely correct. The MDA established for the first time a comprehensive scheme for...
| | 2015 Dietary Guidelines Deliberations Get Underway
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article June 4, 2013, previously published on June 3, 2013 DHHS and USDA announced the inaugural meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC), scheduled for June 13-14. At the inaugural meeting, the DGAC will be provided with an orientation to the process for revising the Dietary Guidelines (revisions take place every five years) and...
| | Recent Kellogg Class Action Settlement is a Reminder that Litigation Over Advertising Claims Often Comes in Several Waves
Katie Bond, James P. Ellison; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 31, 2013, previously published on May 30, 2013 You may not recall our prior April 2009 blog post about the FTC’s settlement with Kellogg over its marketing campaign for Frosted Mini-Wheats. To briefly recap, Kellogg had claimed that “its cereal was “clinically shown to improve kids’ attentiveness by nearly 20%.”...
| | Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 31, 2013, previously published on May 29, 2013 For the third time this year, FDA has been asked to recognize 5-year New Chemical Entity (“NCE”) exclusivity for a fixed-dose combination drug product containing both a never-before-approved active moiety and a previously approved active moiety. In a Citizen Petition (Docket No....
| | FDA Cites Park Doctrine in a Different Context
Katie Bond, Paul M. Hyman; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 30, 2013, previously published on May 28, 2013 As we have discussed previously, the Park doctrine allows the government to seek a misdemeanor conviction against a company official for alleged violations of the Federal Food, Drug, and Cosmetic Act ("FDCA") without having to prove that the official participated in or was even aware of...
| | Egg on its Face: Agency Could Not Impose Sanctions When its Interpretation of its Regulation Was Granted No Deference
Jessica A. Ritsick; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 29, 2013, previously published on May 27, 2013 The Fifth Circuit earlier this month, in Elgin Nursing and Rehab Ctr. v. U.S. Dep’t of Health and Human Servs., No. 12-60086, 2013 WL 2149873 (5th Cir. May 17, 2013), struck down a decision by the Department of Health and Human Services (“HHS”) relating to the Centers for Medicare...
| | FDA Sends Letter to Mobile App Developer for Failure to Obtain 510(k) Clearance
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 24, 2013, previously published on May 22, 2013 FDA has issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to have a 510(k) clearance for its mobile app, the uChek Urine Analyzer. The app can be downloaded for 99 cents through the iTunes Apps Store, and uses the phone’s camera...
| | Fight for Raw Milk Churns On
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 24, 2013, previously published on May 23, 2013 A fight that started as a citizen petition asking FDA to permit the interstate sale of raw milk under limited circumstances is now being waged in federal court.
| | CDRH Issues Final Appeals Guidance, Q&A About FDASIA Appeals Process
Jennifer D. Newberger, Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 23, 2013, previously published on May 20, 2013 As discussed in our prior posts, the Center for Devices and Radiological Health (“CDRH”) has taken much needed steps to improve the most commonly used appeal process, request for supervisory review, available under 21 C.F.R. § 10.75.
| | FDA is Asked to Deviate From ANDA “Exception Excipient” Policy for Generic VFEND Injection; Precedent Indicates Agency Will Remain Firm
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 23, 2013, previously published on May 21, 2013 A Citizen Petition (Docket No. FDA-2013-P-0203) submitted to FDA earlier this year raises an issue that comes up from time to time - although not typically in a public forum - about the Agency’s so-called “exception excipient” regulations applicable to sponsors of ANDAs for...
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