By Kurt R. Karst – Over the past year or so, we’ve seen a change in FDA policy concerning what approvals the sponsor of a 505(b)(2) NDA can cite in an application; that is, what previous FDA approvals a 505(b)(2) sponsor can rely on for the …
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Hyman Phelps McNamara
- When Can’t a “Listed Drug” Serve as a Reference Product for a 505(b)(2) Application?June 19th, 2012
- Food Additive Petition Seeks to Reduce Neural Tube Defects Among HispanicsJune 19th, 2012
By Ricardo Carvajal – In a relatively rare example of a request for regulatory action intended to benefit a specific racial or ethnic group, a coalition of businesses and nonprofits submitted a food additive petition (see here and here) asking FDA to amend the food additive regulation …
- New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been UnsuccessfulJune 17th, 2012
By Kurt R. Karst – A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating. The paper, …
- HP&M Webinar: Garbage Runs, Fake Identities, and Surprise Home Visits: Strategies to Deal With FDA’s Nontraditional Investigative ToolsJune 17th, 2012
Hyman, Phelps & McNamara P.C. invites you to register for our webinar, “Garbage Runs, Fake Identities, and Surprise Home Visits: Strategies to Deal With FDA's Nontraditional Investigative Tools,” which is scheduled to take place on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET. From …
- FDA Makes Institutional Review Board Draft Guidance AvailableJune 14th, 2012
By Anne Marie Murphy & Benjamin K. Wolf* – On June 12, 2012, FDA announced the availability of a draft guidance, titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” (“FDA Draft Guidance”). This is the first time FDA has provided through guidance specific direction …
- Court Rejects FTC’s Effort to Require Two StudiesJune 13th, 2012
By Riëtte van Laack – As we previously reported, the United States District Court for the Southern District of Florida denied the Federal Trade Commission’s (“FTC’s”) motion to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …
- “Bring Out Your Dead” Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddonJune 13th, 2012
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 …
- 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 …