The FDA announced it is postponing the annual registration of medical device establishments for 2008. The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007. Establishments that are already registered for 2007 are valid until …
In a recently published white paper (registration required), Steven Richter, a former FDA official and President and Chief Scientific Officer of Microtest Labs, discusses the regulatory challenges facing combination products. The market for combination products is growing such that it is estimated to reach approximately …
Earlier this month, the Supreme Court issued its unanimous decision in Long Island Care At Home, Ltd. v. Coke, a case concerning compensation for in-home caregivers and the Department of Labor’s (“DOL’s”) interpretation of the Fair Labor Standards Act (“FLSA”). The Court’s decision, although anticipated, …
On June 20, 2007, the United States Court of Appeals for the Eighth Circuit issued a decision in Washington University vs. Catalona affirming the District Court for the Eastern District of Missouri’s holding that neither the medical researcher nor the contributing patients have any ownership …
Our “blogfather” over at the Orange Book Blog already has a preliminary post up about the recent victory in the district court by Bristol-Myers Squibb and Sanofi-Aventis over Apotex relating to the enforceability and validity of the patent on the active ingredient in Plavix. Long …
In chemistry, enantiomers are stereoisomers that are non-superimposable complete mirror images of one another. Enantiomers may be either “right-handed” (dextro-rotary) S(+)-isomers, or “left-handed” (levo-rotary) R(-)-isomers. A racemic mixture is one that has equal amounts of “left- and right-handed” enantiomers of a particular chiral molecule. For …
The Supreme Court once famously characterized the risk-benefit analysis for approving new drugs as follows: “[A] drug is effective if it fulfills, by objective indices, its sponsor’s claims of prolonged life, improved physical condition, or reduced pain. . . . [A] drug is unsafe . …
In a previous post, we reported on an assessment conducted by the Analysis Group, Inc. on the effects of authorized generics on paragraph IV patent certifications. There, the authors concluded that “[t]here is no evidence to suggest that authorized generic entry causes delayed generic entry.” …
There is a wise political maxim, “Fool me once, shame on you; fool me twice, shame on me.” Not to be fooled a second time, the U.S. Senate has passed legislation that would, if enacted, make significant changes in the way FDA handles so-called “generic …
We previously reported that Pfizer submitted a citizen petition (2007P-0110) and a petition for stay of action (2007P-0111) requesting that FDA take certain action with respect to Novartis’s LOTREL (amlodipine besylate; benazepril HCl) subsequent to Pfizer’s decision to revoke (as of midnight March 25, 2007) …
Earlier this week, FDA announced the availability of a draft guidance for industry, titled “Bioequivalence Recommendations for Specific Products.” The draft guidance describes a new process by which FDA will provide, via the Internet, recommendations on how to design product-specific bioequivalence (“BE”) studies to support …
