FDA Law Blog is pleased to announce that we’ve been selected as one of the LexisNexis Top 25 Torts Law Blogs of 2011! Here’s what the folks at LexisNexis had to say: The Top 25 group includes some of the best talent in the blogosphere and …
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Hyman Phelps McNamara
- FDA Law Blog Honored by LexisNexisDecember 1st, 2011
- FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LANovember 30th, 2011
By Kurt R. Karst – In what appears to be the second guidance of its kind, FDA proposed in a draft bioequivalence guidance document issued earlier this week that companies seeking approval to market generic versions of RITALIN LA (methylphenidate HCl) Extended-Release Capsules must, in addition …
- Examination of MDR Reporting Criteria Warranted in Light of Recent Warning LetterNovember 29th, 2011
By Jeffrey K. Shapiro – In our continuing quest to enlighten, we are launching today an occasional series that will examine significant or interesting warning letters involving medical device companies. As you probably know, FDA issues warning letters to allege violations of the Federal Food, Drug, and …
- ICD2 2012 Conference – Fostering Innovation and Translational Research in Support of Public Health and Economic GrowthNovember 28th, 2011
The International Conference on Drug Development (“ICD2”), formerly known as the International Industrial Pharmacy Conference, continues its annual tradition of offering an informal forum for the exchange of ideas concerning the drug discovery and development process. The 2012 conference, which is presented by The University …
- GAO Says FDA Needs to do More to Address “Economic Adulteration”November 27th, 2011
By Kurt R. Karst – Last week, the Government Accountability Office (“GAO”) released a report, titled “Food and Drug Administration: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,” in which the GAO examines FDA’s approaches to detecting and preventing so-called …
- Death, Taxes and DEA Inspections: Dealing with the InevitableNovember 22nd, 2011
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …
- FDA Withdraws Avastin Breast Cancer Indication ApprovalNovember 22nd, 2011
By Kurt R. Karst – Almost a year after having notified Genentech of a proposal to withdraw the approval of Avastin® (bevacizumab) for use with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer, and almost five months after …
- NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code CaseNovember 21st, 2011
By Kurt R. Karst – Less than a month before the U.S. Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Docket No. No. 10-844 (see here and here), concerning whether the patent delisting counterclaim provisions at FDC …
- In Sugar v. HFCS (aka “Corn Sugar”), A Message For Trade Association MembersNovember 20th, 2011
By Ricardo Carvajal – Late last month, a district court issued a ruling of interest in a Lanham Act case brought by sugar producers and trade associations against corn refiners and the Corn Refiners Association ("CRA") over their marketing of high fructose corn syrup ("HFCS"). The …
- Senators Propose Legislation to Allow for Profits on Devices for Rare Diseases, Lifting Limitations on Experts to Serve on Advisory PanelsNovember 17th, 2011
By Jennifer D. Newberger – On Tuesday, November 15th, Senator Al Franken (D-MN) announced the introduction of S. 1865, the “Patient Access to Medical Innovation Act.” The bill is intended to accomplish two goals: first, to allow manufacturers of products granted a humanitarian device exemption ("HDE") to profit …
- The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement AgreementsNovember 16th, 2011
By Kurt R. Karst – On November 16th, Senators Jeff Bingaman (D-NM), David Vitter (R-LA), Sherrod Brown (D-OH), and Jeff Merkley (D-OR) announced the introduction of the Fair And Immediate Release of Generic Drugs Act, or the “FAIR GENERxICS Act,” a draft version of which is …
- FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA ApprovalsNovember 16th, 2011
By Kurt R. Karst – In a lawsuit filed in the U.S. District Court for the District of Columbia, Florida-based Hill Dermaceuticals, Inc. (“Hill”) is seeking declaratory and injunctive relief after FDA approved, on October 17, 2011, three ANDAs submitted by Identi Pharmaceuticals Inc. (“Identi”) – …
- CDRH Issues SOP to Define the Appropriate Management Decision Level for Making Changes to Data Requirements for Premarket SubmissionsNovember 16th, 2011
By Carmelina G. Allis – A persistent industry complaint is that CDRH too often changes data requirements in the middle of a review, or requires data for a new device that was not required for predicate devices. It appears that CDRH has taken a step toward addressing …
- Congress Asks GAO to Examine Adverse Event Reporting for Dietary SupplementsNovember 15th, 2011
By Riëtte van Laack – On November 8, 2011, Senator Durbin and Representative Waxman requested that the U.S. Government Accountability Office ("GAO") determine how the adverse event reporting ("AER") for dietary supplements system is working. Since December 22, 2007, pursuant to the Dietary Supplement and Nonprescription …
- Patent Settlement Agreements Remain in the Spotlight, But Not the Unified Spotlight the FTC Might WantNovember 15th, 2011
By Kurt R. Karst – Politico recently published an opinion piece authored by Federal Trade Commission (“FTC”) Chairman Jon Leibowitz, who is up for reappointment for a second term on the Commission, in which he stated he wanted to throw in his “two cents” on how …