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Hyman, Phelps & McNamara, P.C. Document Search Results (257) Show: results per page Sort by:  | OIG Report Calls Into Question Effectiveness of FDA’s REMS Program
Alexander J. Varond; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 20, 2013, previously published on February 18, 2013 In response to FDA’s increasing reliance on Risk Evaluation and Mitigation Strategies (“REMS”) for the management of risks presented by certain drugs, the US Department of Health and Human Service’s Office of Inspector General (“OIG”) conducted an investigation...
| | First Fruits of FDASIA’s New Device Reclassification Procedure
Jeffrey K. Shapiro; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 18, 2013, previously published on February 17, 2013 We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”). The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify devices (see Food and Drug Administration...
| | Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs
Jessica A. Ritsick; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 18, 2013, previously published on February 15, 2013 This week, the Institute of Medicine (“IOM”) released its report, commissioned by the FDA, “Countering the Problem of Falsified and Substandard Drugs.” The objective was to gain an understanding of the “global public health implications of falsified, substandard, and...
| | A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2013, previously published on February 11, 2013 A rather interesting and unexpected (to most) ANDA approval popped up on FDA’s website late last week. On February 6, 2013, FDA approved Macleods Pharmaceuticals Limited’s (“Macleods’”) ANDA No. 202467 for a generic version of ACTOS (pioglitazone HCl) Tablets, 15 mg,...
| | FDA Denies Petition to Regulate Prescription Prenatal Vitamins Containing Folic Acid under an Rx Monograph
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2013, previously published on February 12, 2013 On February 11, FDA issued its response to a December 2009 citizen petition (Docket No. FDA-2009-P-0587-0013) requesting that FDA issue an order confirming that certain prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and mineral, are...
| | Function Over Form or Form Over Function? Two Petitions Challenge FDA’s NCE Exclusivity Approach for Combination Drugs
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 12, 2013, previously published on February 10, 2013 Two recent citizen petitions submitted to FDA - one from Gilead Sciences, Inc. (“Gilead”) under Docket No. FDA-2013-P-0058, and another from Ferring Pharmaceuticals, Inc. (“Ferring”) under Docket No. FDA-2013-P-0119 - take issue with FDA’s long-standing position that...
| | Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2013, previously published on February 5, 2013 As if on cue after our post yesterday concerning briefing in FTC v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), where the U.S. Supreme Court will consider whether drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) are...
| | From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2013, previously published on February 4, 2013 Excitement is building (and will soon reach fever pitch) over the U.S. Supreme Court’s March 25, 2012 Oral Argument in Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416) concerning whether drug patent settlement agreements (aka “reverse payment...
| | Reissue Patents and FDA’s Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 5, 2013, previously published on February 3, 2013 We don’t like loose ends - especially loose ends in the Hatch-Waxman world! Last June, we posted on FDA’s decisions to require sponsors of ANDAs for generic versions of ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Extended-release Capsules to...
| | New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration
James P. Ellison; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 4, 2013, previously published on January 31, 2013 Earlier this month, the U.S. Sentencing Commission (the “Commission”) issued a Notice of Proposed Amendments to the U.S. Sentencing Guidelines, which are used by federal courts to determine sentences for criminal violations.
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