By Kurt R. Karst – We learned earlier today that Michael M. Landa, Esq. was named as FDA’s new Acting Chief Counsel. Mr. Landa, who will assume his new role on April 13, 2009, has a long history with FDA. Since July 2004, Mr. Landa …
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Hyman Phelps McNamara
- Michael M. Landa Tapped as Acting FDA Chief CounselApril 9th, 2009
- FDA to Complete “Unfinished Business” of Device Classification & Call for PMAsApril 8th, 2009
By Jennifer B. Davis – The April 9, 2009 Federal Register will contain the official notice of an FDA order requiring manufacturers of 25 types of Class III “preamendments” devices to submit information on such devices, including adverse safety and effectiveness data not already submitted …
- FDA Approves COARTEM with Priority Review Voucher; Voucher Market is Untested and UnclearApril 8th, 2009
By Kurt R. Karst – Earlier today, FDA announced the approval of Novartis’ combination drug product COARTEM (artemether; lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms. Accompanying the approval is the first Priority Review Voucher …
- Applying Pediatric Exclusivity After Product Approval; FDA Interpretations About Which You Might Not be AwareApril 7th, 2009
By Kurt R. Karst – FDA’s September 1999 guidance document, “Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act,” includes a section addressing the following question: “If my study qualifies for pediatric exclusivity, to what will the period of pediatric …
- FDA Announces Meeting on Economic AdulterationApril 6th, 2009
By Ricardo Carvajal – FDA has announced that it will hold a public meeting on “economically motivated adulteration” to foster discussion about ways that FDA-regulated industries can “better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health …
- Clinical Investigators and Criminal Liability: The Legal Landscape After U.S. v. PalazzoApril 5th, 2009
By JP Ellison – In U.S. v. Palazzo, the Fifth Circuit recently reversed a trial court’s decision to dismiss criminal charges against a clinical investigator based upon violation of 21 C.F.R. § 312.62(b), which requires such investigators “to prepare and maintain adequate and accurate case …
- VA District Court Grants PhotoCure’s Summary Judgment Motion Challenging PTO’s “First Permitted Commercial Marketing” Interpretation for METVIXIA PTEApril 2nd, 2009
By Kurt R. Karst – We previously reported on a lawsuit filed in July 2008 by PhotoCure ASA (“PhotoCure”) against the U.S. Patent and Trademark Office (“PTO”) after the PTO denied PhotoCure’s application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,034,267 (“the …
- Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?April 2nd, 2009
By Ricardo Carvajal – Among the myriad proposals to overhaul the nation’s ailing food safety system, at least one calls for splitting off FDA’s food safety programs and incorporating them into a new Food Safety Administration ("FSA") within the U.S. Department of Health and Human …
- Lessons to be Learned from the Curious Case of Lawyer Paul KelloggApril 1st, 2009
In the latest “Enforcement Corner” column for the Food and Drug Law Institute’s Update publication, Hyman, Phelps & McNamara, P.C. attorneys JP Ellison and John R. Fleder discuss the indictment, trial, conviction, and sentencing of Berkeley Nutraceuticals’ former in-house counsel Paul Kellogg. Mr. Kellogg’s conviction …
- Federal Court of Appeals Hands FDA A Victory in Custom Medical Device CaseApril 1st, 2009
By Jennifer B. Davis – Earlier this week, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued its opinion in United States v. Endotec, Inc., an appeal from the United States District Court for the Middle District of Florida. We previously …
- FDA Takes Enforcement Action Against Companies Marketing Unapproved Narcotic DrugsMarch 31st, 2009
By Kurt R. Karst – Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct …
- GAO Issues Report on BTC Drug Category; Update of 1995 Report Could Lead to Legislative ProposalMarch 31st, 2009
By Kurt R. Karst – Last week, the U.S. Government Accountability Office (“GAO”) issued a report, titled “Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class.” The report updates the Office’s 1995 report on the same topic (see our previous post here). The updated report was requested …
- CDC Throws a Wet Blanket on SaltMarch 27th, 2009
By Ricardo Carvajal – The latest Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) gives credence to a possible link between higher intake of sodium and an increased risk of hypertension. According to CDC, nearly 70% of U.S. adults …
- A Win for Ornamental Finfish; First New Animal Drug Added to MUMS IndexMarch 26th, 2009
By Susan J. Matthees – FDA announced last week that it had added the first unapproved new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (i.e., the Index) since the Agency began accepting submissions last February. The drug, …
- Scientific Publication Calls for a Second Look at Setting a DRI for EPA and DHAMarch 24th, 2009
By Ricardo Carvajal – In June 2008, the Technical Committee on Dietary Lipids of the International Life Sciences Institute sponsored a workshop titled “Towards Dietary Reference Intakes for Omega-3 Fatty Acids.” A summary of the workshop participants' conclusions is now published in the Journal of …