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Document(s) published by this organization: 252
Show: results per page Sort by:  | “Opioid Spring” Blossoms: FDA Finds “Original” OXYCONTIN Discontinued for Safety or Effectiveness Reasons; Will Not Accept or Approve ANDAs
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 18, 2013, previously published on April 16, 2013 The cherry blossoms are finally in full bloom in Washington, D.C., and so too is FDA’s thinking on one non-abuse-deterrent drug. In a prepublication version of a notice that will be published in the Federal Register on April 18, 2013, FDA has determined that OXYCONTIN (oxycodone...
| | When is a Website Considered Labeling?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 18, 2013, previously published on April 16, 2013 Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food company’s website did not constitute labeling even...
| | The HHS Office of Inspector General Reports on Acute-Care Hospitals’ Ubiquitous Practice of Outsourcing High-Risk Compounded Sterile Products
Jeffrey N. Gibbs, Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 17, 2013, previously published on April 16, 2013 On April 10, 2013, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Memorandum Report titled, “High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them.” The OIG Report provides information about...
| | FTC Annual Report Highlights Commission Focus on Health-Related Advertising
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article April 16, 2013, previously published on April 15, 2013 As it does every spring, the Federal Trade Commission (“FTC”) has released its annual report. The new report, which covers 2012, makes clear that the FTC remains as focused as ever on health-related advertising ¿ especially where advertising allegedly promotes products for weight...
| | FDA’s High Risk Pharmacy Inspections and Enforcement Actions: Coming to a Sterile Compounding Pharmacy Near You?
Jeffrey N. Gibbs, Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 14, 2013 On Thursday, April 11, 2013, FDA published a statement titled, “2013 FDA Pharmacy Inspection Assignment,” addressing the unprecedented recent nationwide wave of aseptic pharmacy inspections. The Agency states that it had taken critical look at its surveillance and enforcement approach...
| | Generic BAYTRIL Approval Suspended; Bayer Alleges ANADA Approval Violates GADPTRA and APA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 15, 2013 “GADPTRA” - Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman equivalent for generic animal drugs. Our only...
| | The President’s FY 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity; Biologics Exclusivity Faces Opposition in TPP Talks
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 11, 2013 Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new user fee revenue, making the increase a bit...
| | Federal Judge Grants Defendants’ Motion for Summary Judgment in “All Natural” Lawsuit
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 15, 2013, previously published on April 10, 2013 On March 28, U.S. District Court Judge Richard Seeborg of the Northern District of California entered summary judgment for the defendants in a 2010 class-action lawsuit which had alleged that defendants misrepresented AriZona Iced Tea beverages containing “man-made” citric acid and high...
| | Food Traceability: Recordkeeping Without Regard to Risk?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 9, 2013 Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious...
| | D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 9, 2013 As food and drug attorneys, we rely on a certain level of FDA transparency to understand why FDA did what it did in a particular case, and to discern what that means for future Agency action (or inaction) in another case. One way we get the transparency we need is by submitting Freedom of...
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