By Kurt R. Karst – Each year around this time, some of us at our firm participate in a version of The Price Is Right Showcase Showdown in which folks “bid” on what they think the PDUFA application user fee rate will be set at for …
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Hyman Phelps McNamara
- PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K)July 31st, 2011
- IOM Recommends Replacing 510(k) Clearance Process “As Soon As Reasonably Possible”July 29th, 2011
By Jennifer D. Newberger – On July 29, 2011, the Institute of Medicine ("IOM") released its long-awaited report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” Both industry and FDA were likely surprised by the IOM’s recommendation: do away with the …
- 2 = 2, Unless the 2 are in “ONE A DAY”July 28th, 2011
By Ricardo Carvajal – A federal district court dismissed with prejudice a claim that Bayer’s labeling of gummy vitamins violated the Arkansas Deceptive Trade Practices Act. Plaintiff alleged that the brand name “ONE A DAY” is misleading because the daily serving size for the vitamins is …
- FDA Denies Citizen Petition Requesting PPA ReclassificationJuly 27th, 2011
By Susan J. Matthees – FDA recently denied a 2006 citizen petition submitted by Wyeth Consumer Healthcare (“Wyeth”) requesting that FDA withdraw a 2005 Notice of Proposed Rulemaking (“NPRM”) that would reclassify phenylpropanolamine (“PPA”) from Category I (generally recognized as safe and effective) to Category II (not …
- HP&M Requests One-Year Comment Period for Draft NDI GuidanceJuly 26th, 2011
On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient ("NDI") notifications that FDA issued earlier this month. Our …
- FDA Issues Draft Guidance, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”July 26th, 2011
By Jennifer D. Newberger – On July 27, 2011, the Center for Devices and Radiological Health ("CDRH") announced the issuance of a Draft Guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” When finalized, this guidance document will …
- District Court Says “Shall” Means “Must” in Challenge to PTO Denial of Interim Patent Term ExtensionJuly 25th, 2011
By Kurt R. Karst – Late last week, the U.S. District Court for the Eastern District of Virginia granted the U.S. Patent and Trademark Office’s (“PTO’s”) Motion for Summary Judgment in a challenge mounted by the Genetics & IVF Institute (“GIVF”) to the PTO’s August 2010 …
- FDA Issues Draft Guidance Document on Mobile Medical AppsJuly 24th, 2011
By Carmelina G. Allis – The FDA’s “Draft Guidance on Mobile Medical Applications” is applicable to software products (or “mobile apps”) intended for use on mobile platforms that are handheld in nature, such as, for example, the iPhone® and Android® phones. “Mobile medical apps” are defined …
- Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book ListingJuly 21st, 2011
By Kurt R. Karst – FDA has been asked for a fourth time to provide an advisory opinion on compliance with the Hatch-Waxman Orange Book patent listing requirements for a patent that claims a drug delivery device integral to the administration of the active ingredient, but …
- The Scope of New Chemical Entity Exclusivity and FDA’s “Umbrella” Exclusivity PolicyJuly 20th, 2011
By Kurt R. Karst – Suppose FDA approves a New Drug Application (“NDA”) – NDA No. 1 – and grants a period of 5-year New Chemical Entity (“NCE”) exclusivity, but there are no patents listed in FDA’s Orange Book for the NDA, and therefore, there is …
- Can Efforts to Develop an Integrated Food Safety System Advance in the Face of State Budget Crises?July 19th, 2011
By Ricardo Carvajal – The integration of federal and state food safety systems is one of the goals of the Food Safety Modernization Act. To that end, FDA recently announced the availability of grant funding to help with the “design, development, delivery, and maintenance of a …
- Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA ApprovalJuly 18th, 2011
By Kurt R. Karst – Last week, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia dismissed without prejudice for lack of subject matter jurisdiction a Complaint filed by Cephalon, Inc. (“Cephalon”) on March 15, 2011 challenging FDA’s January 7, 2011 …
- FDA’s NDI Guidance and the 18-Year Cycle of Correcting Regulatory OverreachJuly 14th, 2011
By Wes Siegner, Ricardo Carvajal & Riëtte van Laack – Since at least the early 1960s, FDA has attempted to exercise control over the dietary supplement market, sometimes in ways that the public, industry and Congress have found unacceptable. In the 60s, FDA proposed a regulation …
- The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTOJuly 14th, 2011
By Kurt R. Karst – A recent article published in Roll Call, titled “Hatch-Waxman Act’s Interpretations Threaten Lives, Jobs,” caught our attention. The article was penned by Delegate Donna Christensen (D-VI) (who is chairwoman of the Congressional Black Caucus Health Braintrust) and expresses the strong support …
- FDA Issues Draft Companion Diagnostic Guidance; FDA Generally Will Require Approval or Clearance of Diagnostic at Same Time As Approval of Therapeutic if Safety and Efficacy of Therapeutic Depends on DiagnosticJuly 13th, 2011
By Jamie K. Wolszon – FDA announced earlier this week the publication of a much-anticipated draft guidance on in vitro companion diagnostic devices. In the draft guidance, FDA stakes out a policy position that if safe and effective use of a therapeutic depends on a diagnostic, …