By Kurt R. Karst – Last Friday, a group of Republican Senators (Sens. Jeff Sessions (R-AL), Tom Coburn, (R-OK), John Cornyn (R-TX), and John Thune (R-SD)) sent a letter to Senate Republican leaders expressing their “vigorous objection” to the inclusion of the “Preserve Access to …
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. (Please register by September 29th.) In criminal prosecutions of corporate executives, ignorance of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law firm in the area of FDA Law. Only six firms made it to the top …
By Kurt R. Karst – FDA will soon announce in the Federal Register a two-day public hearing (November 2 and 3, 2010) to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 …
By Kurt R. Karst – Do you have an ANDA prior approval supplement pending at FDA? How long has it been pending – 6 months? One year? 18 months? Well it might still some time until there is any action on it. Over the …
By Ricardo Carvajal – A district court dismissed a complaint alleging consumer fraud in food labeling that highlights the presence of fiber. Plaintiff alleged that defendants violated state consumer fraud laws by failing to disclose that their products contain alleged “non-natural” fibers that “have not …
It’s that time of year again when the Blawggeratti (legal bloggers) are all atwitter about the American Bar Association’s (“ABA’s”) Blawg 100 – the top 100 legal blogs in the blogosphere. With your help we made the top 100 list last year, and we are …
By Kurt R. Karst – How much is the potential for four month being lopped off your NDA review period (i.e., the difference between FDA’s standard and priority review goals under PDUFA)? FDA set the baseline earlier this week when the Agency issued a …
By Kurt R. Karst – Earlier this week, Senator Patrick Leahy (D-VT) introduced the Food Safety Accountability Act of 2010 (S. 3767). The bill, which follows Sen. Leahy’s Food Safety Enforcement Act of 2010 (S. 3669) introduced earlier this year and the recent egg …
By Kurt R. Karst – It was not a question of whether ViroPharma Incorporated (“ViroPharma”) would sue FDA in connection with the approval of ANDAs for generic versions of the company’s antibiotic drug of last resort, VANCOCIN (vancomycin HCl) Capsules, but when. In addition …
By Nisha P Shah – In a letter to the Electronic Cigarette Association, FDA stated its intention to regulate electronic cigarettes (also referred to as e-cigarettes or e-cigs) as drug products. Specifically, FDA maintained that e-cigarettes “meet the definitions of both a drug and device …
By Kurt R. Karst – Earlier today (September 9th), in a notice filed with the U.S. District Court for the Eastern District of Virginia (Alexandria Division), the government informed the court that “the Solicitor General has, at this time, elected against appeal” of Judge …
By Ricardo Carvajal – In late August, FDA issued warning letters to Unilever and Dr. Pepper Snapple Group objecting to the use of unauthorized nutrient content claims for antioxidants in the labeling of certain products containing green tea. Similar warning letters addressing other types of …
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Second circuit denied without comment a Petition for Rehearing and Rehearing En Banc filed on behalf of certain plaintiffs-appellants in In Re Ciprofloxacin Hydrochloride Antitrust Litig,, an antitrust challenge to …
By Ricardo Carvajal – Section 10(b) of the Exchange Act and Securities and Exchange Commission (“SEC”) Rule 10b-5 prohibits “any act, practice, or course of business which operates or would operate as a fraud or deceit upon any person, in connection with the purchase or …
