By Dara Katcher Levy & Diane B. McColl - Last week, FDA issued a draft guidance intended to assist sponsors and investigators with decisions as to whether human research studies can be conducted on products without an investigational new drug application ("IND"). The draft guidance explains …
By Kurt R. Karst – Earlier this week, the Institute of Medicine (“IOM”) issued a 350-page report, titled “Rare Diseases and Orphan Products: Accelerating Research and Development,” which is intended to help refocus attention on accelerating rare diseases research and product development. The report is the …
By John A. Gilbert & William T. Koustas – The United States Congress passed the Secure and Responsible Drug Disposal Act of 2010 (“the Act”) on September 29, 2010, and it is soon expected to be signed into law by the President. This Act is intended …
By Jeffrey N. Wasserstein & David B. Clissold – In a move that signals the future of medical product development, the Food and Drug Administration ("FDA") and the Centers for Medicare and Medicaid Services ("CMS") announced that they are considering establishing a parallel review process for …
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 – 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 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 …
By Kurt R. Karst – The dispute between Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) and FDA over marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL drug products did not end with the July 26, 2010 decision from the U.S. District Court for the District …
By William T. Koustas – Franck’s Lab, Inc. (“Defendant”), an Ocala, Florida veterinary compounding pharmacy, resumed compounding after a federal judge in the United States District Court for the Middle District of Florida denied the Government’s (“Plaintiff”) request for a preliminary injunction on August 19, 2010 that …
By Nisha P. Shah – At the conclusion of a multi-year federal investigation, Allergan Inc. ("Allergan") announced today it has reached a settlement with the U.S. Department of Justice (DOJ) and will pay $600 million to resolve criminal and civil claims related to the sales and …
By Kurt R. Karst – Responding to a request from certain Members of Congress, the U.S. Government Accountability Office (“GAO”) has released a report evaluating FDA’s use of evidence from non-inferiority trials to establish a drug’s effectiveness and support approval of new therapies. As …
By Kurt R. Karst – On August 16, 2010, FDA announced that the Agency plans to follow through on previous correspondence threatening to withdraw approval of all marketing applications for the Subpart H (accelerated approval) drug Midodrine HCl. FDA also issued a Notice of …
By Kurt R. Karst – The 60 Plus Association, a senior advocacy group and alternative to AARP, has joined the debate over marketed unapproved drugs, asking FDA to step-up enforcement action and starting its “Keep Seniors Safe” initiative, which “advocates the removal of unapproved …
By William T. Koustas – We have previously written that Regenerative Sciences (“Regenerative”), a Colorado-based stem cell company, filed a complaint in the U.S. District Court for the District of Columbia against FDA in order to enjoin it from regulating Regenerative’s use of cultured stem …
By Kurt R. Karst – Yesterday, Senator Sam Brownback (R-KS) (along with Sen. Sherrod Brown (D-OH)) introduced S. 3697, the Creating Hope Act of 2010. The bill would amend FDC Act § 524 to change the transferable Priority Review Voucher (“PRV”) program created by …
