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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | 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.
| | FDA Advisory Committee Votes 19 to 10 In Favor of Rescheduling Combination Hydrocodone
Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 1, 2013, previously published on January 30, 2013 Last Friday, January 25, 2012, after two days of discussion and deliberation, an FDA Advisory Committee voted 19 to 10 in favor of rescheduling combination hydrocodone from its current placement in Schedule III to Schedule II.
| | FDA Finalizes Guidance on Humanitarian Use Device Designations
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 31, 2013, previously published on January 29, 2013 On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a “medical device intended to benefit...
| | Blunt Talk from the D.C. Circuit: No “Adequate and Well-Controlled Studies Exist” on Marijuana’s Medical Efficacy; Dismisses Appeal of DEA’s Denial of Marijuana Rescheduling Petition
Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 29, 2013, previously published on January 27, 2013 On January 22, 2013, the United States Court of Appeals for the District of Columbia Circuit dismissed a petition for review filed by several interest groups and individuals who petitioned DEA to initiate the federal rescheduling of marijuana. The case stems back to a 2002 Citizens Petition filed...
| | Government Does Not Seek Further Second Circuit Review in Caronia
Hyman Phelps McNamara P.C.;
Legal Alert/Article January 29, 2013, previously published on January 18, 2013 On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the criminal conviction of Alfred Caronia. The court ruled that the government could not prosecute pharmaceutical representatives such as Mr. Caronia for speech promoting the lawful, off-label use of an...
| | HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations
Jeffrey N. Wasserstein; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 29, 2013, previously published on January 22, 2013 On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its much anticipated (and long-awaited) final rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security and Enforcement Rules under the...
| | FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” Defined
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 28, 2013, previously published on January 24, 2013 The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. 78 Fed. Reg. 4307 (Jan. 22, 2013). This rule finalizes a proposed rule issued on September 23, 2009. The new rule, which appears in a newly added section to Title 21,...
| | Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 28, 2013, previously published on January 23, 2013 Last week, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) filed what might be the company’s last motion in its preemptive lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory relief...
| | Biosimilar Substitution: Battles are Brewing at the State Level
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 28, 2013, previously published on January 17, 2013 Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) - let alone consider...
| | FTC Hammers POM Wonderful: Now On to the World Series
John R. Fleder, Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 18, 2013, previously published on January 17, 2013 On January 16th, the Federal Trade Commission ("FTC") issued the long-anticipated Decision and Final Order in the FTC’s administrative case filed in 2010 against POM Wonderful LLC, Roll Global LLC, Stewart A. Resnick, Lynda Rae Resnick, and Matthew Tupper (collectively...
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