By Jennifer D. Newberger – On August 15, 2011, FDA released two Draft Guidances: “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices.” Each is discussed in turn below. Factors to Consider when Making …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
By Riëtte van Laack – FDA is reopening the comment period on the proposed rule it published on December 8, 2010, to amend the regulations on plant sterol/stanol esters and risk of coronary heart disease. (See our previous post on the proposed rule.) One of FDA’s proposed …
By Kurt R. Karst – With all of the hullabaloo that has been going on in court and on Capitol Hill in the continuing battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 Patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) …
By Kurt R. Karst – FDA recently denied (here and here) two citizen petitions (here and here) submitted on behalf of ECR Pharmaceuticals (“ECR”) and Laser Pharmaceuticals, LLC (“Laser”) requesting that FDA, among other things, reconsider its determinations that certain marketed unapproved drug products containing brompheniramine …
By Susan J. Matthees – Apparently as a result of a misunderstanding of the basic principles of homeopathy, and how of necessity the efficacy testing for such drugs differs from non-homeopathic drugs, a judge in the U.S. District Court for the Central District of California recently decided …
By Kurt R. Karst – FDA’s recent approval of ANDA No. 090358 for an AB-rated generic version of IMITREX STATdose (sumatriptan succinate) Injection, approved under NDA No. 020080, puts some meat on the bones of the Agency’s July 2009 consolidated response to two citizen petitions (here …
By Kurt R. Karst – The latest battleground over the period of exclusivity that should apply to biological products is the Trans-Pacific Partnership (“TPP”) trade agreement. As you might recall, earlier this year there was quite a hubbub over whether the 12-year reference product exclusivity period provided …
By Cassandra A Soltis – In a decision that could have implications in the United States, the U.K.’s Advertising Standards Authority (“ASA”), which describes itself as “the UK’s independent watchdog” that regulates advertising, found both a Lancôme and a Maybelline advertisement misleading because the images of …
By Cassandra A. Soltis – The Food and Drug Administration (“FDA”) has reopened the comment period for its proposed rule on “gluten-free” labeling of food to announce the availability of, and seek comments on, its report titled “Health Hazard Assessment for Gluten Exposure in Individuals with …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C.’s Douglas B. Farquhar discusses the recent and highly publicized directed verdict for Lauren Stevens, the former in-house lawyer at GlaxoSmithKline, who was on trial for charges that she, basically, lied to the …
The American Conference Institute will be holding its 12th annual “Maximizing Pharmaceutical Patent Life Cycles” conference in New York City from October 3-5, 2011. A copy of the conference program is available here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be presenting at …
By Ricardo Carvajal – The Federal Trade Commission ("FTC") issued the latest in a series of reports on sales, advertising, and promotion of cigarettes and smokeless tobacco. The reports are based on data submitted to FTC by industry. The cigarette report states that the “total number …
The Institute of Food Technologists (“IFT”) is requesting proposals for its March 28-29, 2012 annual Wellness Conference, which will explore new trends and examine recent scientific, technological, and business information in the health and wellness sector of the food industry. The conference will cover a …
By Cassandra A. Soltis & Anne Marie Murphy – The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on …
