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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 2, 2013, previously published on March 31, 2013 Depite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company - or FDA - misses a deadline by just one day, then opportunities provided by the statute can be...
| | OIG Issues Special Fraud Alert on Physician Owned Distributorships
Alan M. Kirschenbaum, Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 1, 2013, previously published on March 27, 2013 Yesterday the OIG issued a Special Fraud Alert on physician owned distributorships, or PODs. The OIG describes these entities as “physician owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician owners in...
| | Disclosures in a Small Space: The FTC’s Revisions to .Com Disclosures
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article April 1, 2013, previously published on March 27, 2013 Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones had not yet met the internet and social media barely existed. In the new version...
| | GAO Suggests Ways to Improve FDA’s Oversight of Dietary Supplement Safety
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 28, 2013, previously published on March 26, 2013 On March 18, 2013, the Government Accountability Office ("GAO") released a report addressing FDA’s use of Adverse Event Reports ("AERs") in overseeing dietary supplements. Specifically, GAO examined (1) the number and source and the types of dietary supplements identified...
| | The Big Day Approaches: Supreme Court to Hear Oral Argument in ANDROGEL Drug Patent Settlement Agreement Case
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 27, 2013, previously published on March 24, 2013 Excitement is running high in the pharmacetical world with just hours to go before the U.S. Supreme Court hears oral argument on Monday, March 25, 2013 in Federal Trade Commission v. Actavis (Docket No. 12-416) concerning whether drug patent settlement agreements (aka “reverse payment...
| | Cytori Case Decision Upholds FDA’s Not Substantially Equivalent Determination
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 27, 2013, previously published on March 24, 2013 The U.S. Court of Appeals for the D.C. Circuit (appeal no. 11-1268) issued a decision last Friday backing up FDA’s denial of 510(k) clearance to two of Cytori’s products, the Celution 700 and the StemSource 900, which are intended to harvest cells from adipose (fat) tissue. Cytori...
| | New Legislation Would Schedule Any Substance Containing Hydrocodone in Schedule II; Leaves Hydrocodone Combination Product Storage Requirements for Non-Practitioners Consistent with Schedule III
Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 22, 2013, previously published on March 21, 2013 Senators Joe Manchin (D-W.Va.) and Mark Kirk (R-IL), along with Representatives Vern Buchanan (R-FL) and Edward Markey (D-MA) introduced on March 20, 2012 bipartisan, bicameral legislation to combat prescription drug abuse by attempting to tighten restrictions on what they characterize as some of...
| | Second Circuit Comes to a Split Decision on Standing in NRDC Lawsuit Over OTC Triclosan and Triclocarban Products
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 22, 2013, previously published on March 19, 2013 Earlier this week, the U.S. Court of Appeals for the Second Circuit issued a decision that paves the way for the Natural Resources Defense Council (“NRDC”) to pursue its action to compel FDA to finalize the Agency’s review and regulation of topical antimicrobial drug products...
| | Appeal in NYC Sugary Drinks Case Set for June; Decision by Judge Tingling Cites Loopholes and Questions Imminence of Danger Due to Obesity; State of Mississippi Responds
Etan J. Yeshua; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 22, 2013, previously published on March 20, 2013 New York City's portion cap rule will have its day in court (again) in early June. The rule, which would have fined food service establishments for each sugary drink sold in a container larger than 16 ounces, was challenged and struck down last week by a New York State Supreme Court judge who...
| | Preemption, Preemption, and More Preemption - A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. Bartlett
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article March 19, 2013, previously published on March 18, 2013 Over the past week we’ve been inundated with new items concerning generic drug labeling and whether federal law - the FDC Act and FDA’s implementing regulations - preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against...
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