By William T. Koustas – FDA recently issued its most extensive guidance for industry regarding Risk Evaluation and Mitigation Strategies (“REMS”) since their enactment of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The “Draft Guidance for Industry: Format and Content of Proposed …
By William T. Koustas – The United States Court of Appeals for the District of Columbia Circuit (“Court”) recently issued an opinion affirming the FDA’s (or “Agency”) approval of the anthrax vaccine for all known routes of infection and rejected the Plaintiffs’ efforts to enjoin …
By Jeffrey K. Shapiro – FDA’s Office of Combination Products (“OCP”) recently issued a proposed rule (74 Fed. Reg. 48,423) setting forth current good manufacturing practice (“cGMP”) requirements for combination products. The proposed rule does not independently establish new requirements; rather, it clarifies which set of …
By Alan M. Kirschenbaum – The Senate Finance Committee began today to mark up its healthcare reform bill, the America’s Healthy Future Act of 2009. In a previous post, we provided an outline of the provisions of the Chairman’s Mark that would specifically affect drug …
By Kurt R. Karst – Over the past several weeks there has been growing chatter about FDA’s Document Archiving, Reporting and Regulatory Tracking System (“DARRTS”) and how its implementation might affect generic drugs. DARRTS is a Center for Drug Evaluation and Research (“CDER”) information technology …
By Carrie S. Martin – On September 21, 2009, FDA announced in a Federal Register notice that the Agency plans to hold a public hearing to discuss issues regarding the promotion of FDA-regulated products – specifically prescription drugs, prescription biologics, and medical devices – via the …
By Alan M. Kirschenbaum – Today the Senate Finance Committee (“SFC”) released the Chairman’s Mark of the “America’s Healthy Future Act of 2009,” which currently is scheduled for Committee mark up next Tuesday, September 22. Among the various health reform proposals in the House and Senate, …
By Douglas B. Farquhar – Pharmaceutical manufacturer Pfizer has agreed to the largest drug marketing settlement yet – $2.3 billion (yes, that is “billion” with a “b”) to resolve claims originally brought by six whistleblowers that the firm illegally marketed four drugs – according to …
By Susan J. Matthees – After years of anticipation, FDA has finally published a final rule establishing a specific small number of animals for each of the seven major species for purposes of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). …
By Kurt R. Karst – On August 12th, FDA announced the publication of final regulations concerning “Expanded Access to Investigational Drugs for Treatment Use” and “Charging for Investigational Drugs Under an Investigational New Drug Application.” Both rules will be officially published in the August 13th …
By Kurt R. Karst & Michelle L. Butler – Winston Laboratories, Inc. (“Winston”) recently sued FDA after the Agency denied a waiver of the Prescription Drug User Fee Act (“PDUFA”) application fee assessed with respect to the company’s human drug application (NDA No. 22-403) for …
By Kurt R. Karst – Earlier this week FDA issued several Federal Register notices setting the Fiscal Year (“FY”) 2010 user fee rates for human drugs under the Prescription Drug User Fee Act (“PDUFA”), for medical devices under the Medical Device User Fee and Modernization …
By Alan M. Kirschenbaum – As we reported on August 2, the House Energy and Commerce Committee last Friday reported out its healthcare reform bill, the America’s Affordable Health Choices Act (H.R. 3200). In order to help finance healthcare reform, the bill contains numerous provisions that …
By Carrie S. Martin – Last Wednesday, the Senate Special Committee on Aging held a hearing to discuss the conflicts of interest presented by the funding of continuing medical education (“CME”) by pharmaceutical and medical device companies. Lewis Morris, Chief Counsel to the Office of …
By William T. Koustas – Last week, FDA announced the approval of Onsolis (fentanyl buccal soluble film) with a substantial Risk Evaluation and Mitigation Strategy ("REMS"), as well as a boxed warning. Onsolis is a potent opioid that is administered through the mucous membranes of …
