By Kurt R. Karst – In a move that brings to mind Scene 2 of Monty Python and the Holy Grail, in which a mortician roams the streets ringing a bell and calling out “Bring out your dead!” (a close second being the Monty Python “Dead …
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Hyman Phelps McNamara
- “Bring Out Your Dead” Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddonJune 13th, 2012
- FDA Should Be Required To Provide 510(k) Decision SummariesJune 12th, 2012
By Jeffrey K. Shapiro – A provision in the House FDA Reform Act of 2012 (H.R. 5651) would require FDA to “regularly publish detailed decision summaries for each clearance of a device requiring clinical data” (Section 704). The requirement would be applied only on a going …
- OIG Releases Report Regarding Scientific Disagreements at CDRHJune 11th, 2012
By Jennifer D. Newberger – On June 5, 2012, the Department of Health and Human Services Office of Inspector General (“OIG”) released a report titled “Scientific Disagreements Regarding Medical Device Regulatory Decisions.” A number of scientific disputes at the Center for Devices and Radiological Health (“CDRH”) …
- Etched Citrus Coming Your Way!June 10th, 2012
By Diane B. McColl - The days of having to deal with those pesky adhesive labels on citrus fruit may be over. FDA has announced a final rule approving the use of a carbon dioxide laser for etching information, such as product code, on the surface of …
- House Passes Bill to Repeal Medical Device Excise Tax; Veto Threat LoomsJune 7th, 2012
By Kurt R. Karst – In a late-day vote, the U.S. House of Representatives passed H.R. 436, the Health Care Cost Reduction Act of 2012 (formerly titled the Protect Medical Innovation Act of 2012), by a 270-146 vote. Among other things, the bill repeals the medical …
- FDA Takes Another Hit in Court in Animal Feed Antibiotics Litigation; Court Says Agency’s Petition Denials Are Arbitrary and CapriciousJune 6th, 2012
By Kurt R. Karst – Magistrate Judge Theodore H. Katz of the U.S. District Court for the Southern District of New York has dealt FDA another loss in litigation over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals. In …
- FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization LegislationJune 5th, 2012
By Kurt R. Karst – As the U.S. Senate and U.S. House of Representatives geared up last month to consider bills in their respective chambers to, among other things, reauthorize and amend old and establish new user fee statutes, one FTC Commissioner – Commissioner J. Thomas …
- HP&M’s Jeff Gibbs to Speak at FDLI Medical Device Regulation and Litigation ConferenceJune 5th, 2012
Hyman, Phelps & McNamara, P.C. Director Jeffrey N. Gibbs is a featured speaker at the Food and Drug Law Institute’s upcoming Medical Device Regulation and Litigation Conference. The conference is schedule to take place on July 18, 2012 at The Madison Hotel in Washington, DC. A …
- HP&M’s Jeff Shapiro to Present on Medical Device Risk-Benefit FDA GuidanceJune 4th, 2012
Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro is the featured presenter in a 90-minute webinar hosted by Elsevier Business Intelligence, titled “Discover the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance.” The webinar is scheduled for June 19, 2012 at 1:00 PM …
- FTC Could Revise its Dot Com Disclosures Guidelines by Fall 2012June 3rd, 2012
By Jennifer M. Thomas – Last week, the Federal Trade Commission (“FTC”) hosted a workshop entitled “In Short: Advertising and Privacy Disclosures in a Digital World.” The workshop was intended to explore whether the FTC needs to revise its online advertising disclosure guidelines (“Dot Com Disclosures”), …
- A Sweet Day for SugarJune 1st, 2012
By Ricardo Carvajal - FDA denied a citizen petition submitted by the Corn Refiners Association ("CRA") which asked FDA to authorize the use of “corn sugar” as a common or usual name for high fructose corn syrup ("HFCS"), and to amend certain regulations that reference “corn …
- House Passes FDA Reform Act of 2012; Next Up – Conference CommitteeMay 31st, 2012
By Kurt R. Karst – After a round of congratulatory speeches, the U.S. House of Representatives passed H.R. 5651, the FDA Reform Act of 2012, as amended, on May 30th by a vote of 387-5. Unlike the U.S. Senate, which passed its version of the bill …
- Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition CaseMay 30th, 2012
By Kurt R. Karst – In a recent, 95-page decision from the U.S. District Court for the Eastern District of Pennsylvania in In re Wellbutrin XL Antitrust Litigation, the court once again tackled the issues of “sham” citizen petitions, liability under the Sherman Antitrust Act, and …
- Making the House FDA Reform Act of 2012 PAYGO Compliant – Are Expedited 505(q) Citizen Petition Responses the Answer?May 28th, 2012
By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
- U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House BillMay 25th, 2012
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …